[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-advanced-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-advanced-non-small-cell-lung-cancer":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,55,87,108,130,171,196,216,277,299,321,348,370,388,415,443,462,491,513,538,558,581,606,631,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100583857","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-ras-mutated-nsclc-rasolve-301-100583857",false,"NCT06881784","Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","RASolve 301","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* One to two prior lines of therapy including an anti-PD-1\u002Fanti-PD(L)-1 agent and platinum-based chemotherapy.\n* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy or docetaxel.\n* Untreated central nervous system (CNS) metastases.\n* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).\n* Ongoing anticancer therapy.\n* Pregnant or breastfeeding.","ALL","18 Years",{"count":21,"type":22},590,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.",[28,29,30,31,32],"NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Cancer","NSCLC","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC (Advanced Non-small Cell Lung Cancer)",[30,29,34,35,36,37,38,39,40,41],"Lung Cancer","RAS","KRAS","HRAS","NRAS","RAS Q61 Mutation","RAS G12 Mutation","RAS G13 Mutation","RECRUITING","2026-06-24",{"date":45,"type":46},"2026-06-25","ACTUAL",{"date":48,"type":46},"2025-05-06",{"date":50,"type":22},"2030-12-01",{"name":52,"class":53},"Revolution Medicines, Inc.","INDUSTRY",151,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100637833","phase-2-becotatug-vedotin-combined-with-pucotenlimab--radiotherapy-as-first-line-treatment-for-driver-gene-negative-egfr-expression-positive-advanced-non-small-cell-lung-cancer-100637833","NCT07627321","Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer","PRAD2: A Prospective, Single-Arm, Multi-Center, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer","PRAD2","Inclusion Criteria:\n\n1. Voluntary participation with written informed consent obtained prior to any study-specific procedures, and willingness to comply with the study requirements.\n2. Male or female patients aged between 18 and 75 years (inclusive) at the time of signing informed consent.\n3. Histologically or cytologically confirmed Stage IV (M1a, M1b, or M1c according to the AJCC 8th Edition) squamous or non-squamous NSCLC.\n4. No prior systemic therapy for advanced\u002Fmetastatic disease is permitted. Patients who received adjuvant\u002Fneoadjuvant chemotherapy and relapsed ≥6 months after the last dose are allowed to enroll.\n5. At baseline, presence of at least one measurable target lesion outside the primary tumor per RECIST v1.1, which is suitable for accurate repeated measurement and has not been previously irradiated or treated with other local therapies.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Absence of known actionable driver gene alterations (e.g., EGFR, ALK, ROS1) in both squamous and non-squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory.\n8. Immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher.\n9. Medically fit to tolerate radiotherapy, with an expected survival of ≥12 weeks.\n10. No prior exposure to Antibody-Drug Conjugates (ADCs).\n11. Adequate organ and bone marrow function as defined below (within 14 days prior to initiation of study treatment):\n\n    \\- Hematology (must not have received blood transfusions, granulocyte colony-stimulating factor \\[G-CSF\\], or hematopoietic growth factors within 14 days prior to screening):\n\n    \\- Hemoglobin (Hb) ≥ 90 g\u002FL;\n\n    \\- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n\n    \\- Platelets (PLT) ≥ 75 × 10⁹\u002FL.\n\n    \\- Blood Chemistry (must not have received albumin infusion within 14 days prior to screening):\n    * Total Bilirubin (TBIL) ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome);\n    * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5.0 × ULN;\n    * Serum Creatinine (Cr) ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula):\n\n    Male: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine) Female: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine) × 0.85 (Note: Weight in kg; Serum creatinine in mg\u002FdL)\n\n    \\- Coagulation Function:\n    * International Normalized Ratio (INR) ≤ 2.0 or Prothrombin Time (PT) ≤ 6 seconds above the upper limit of normal.\n12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test cannot be definitively confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive.\n13. Female subjects of childbearing potential who are sexually active with unsterilized male partners must agree to use highly effective contraception starting at screening and continue for 180 days after the last dose of study drug.\n14. Sexually active male subjects who have not undergone sterilization and who are sexually active with female partners of childbearing potential must agree to use effective contraception starting at screening and continue for 180 days after the last dose. Decisions regarding the cessation of contraception beyond this timeframe should be discussed with the investigator.\n15. Subjects must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1\\. Prior receipt of any systemic anti-tumor therapy for advanced, recurrent, or metastatic NSCLC, or perioperative therapy completed less than 6 months prior to enrollment.\n\n2\\. History of another malignancy within 5 years prior to enrollment (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n\nKnown hypersensitivity to Becotatug vedotin, Pucotenlimab, or any of their excipients.\n\n3\\. Prior treatment with any of the following: ADCs, PD-1\u002FPD-L1 inhibitors, CTLA-4 inhibitors, or bispecific antibodies targeting immune checkpoints.\n\n5\\. History of severe bleeding tendency or coagulation dysfunction; significant clinically significant bleeding symptoms within 1 month prior to the first dose (including but not limited to gastrointestinal bleeding, hemoptysis \\[defined as expectoration of ≥1 teaspoon of fresh blood or blood clots, or pure hemoptysis without sputum; subjects with blood-streaked sputum are allowed\\]); nasal hemorrhage (excluding simple epistaxis and post-nasal drip with blood); imaging at screening showing tumor encasement of major vessels, significant tumor necrosis, or cavitation deemed by the investigator to pose a high bleeding risk; central or cavitary squamous NSCLC deemed high-risk for bleeding by the investigator; receipt of continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose.\n\n6\\. Tumor invasion of surrounding vital organs or vessels (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus) or presence of risk factors for esophagotracheal fistula or esophagopleural fistula.\n\n7\\. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (subjects not requiring drainage or requiring drainage less than once per month are allowed).\n\n8\\. Arteriovenous thromboembolic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those judged by the investigator to be fully resolved and related to venous catheters for prior chemotherapy), and pulmonary embolism.\n\n9\\. Symptomatic brain metastases. Subjects with brain metastases that have been treated and remain clinically stable for at least 1 month, and who have discontinued corticosteroids and anticonvulsants for at least 1 month prior to study entry, are allowed.\n\n10\\. Inability to provide documentation of driver gene-negative status or IHC evidence confirming EGFR expression ≥2+.\n\nComorbidities\u002FMedical History:\n\n11\\. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg);\n\n\\- Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class II or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure;\n\n* Conditions significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or clinically significant intestinal obstruction;\n* Renal insufficiency: urinalysis indicating proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0 g;\n* Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU\u002FmL; Hepatitis C defined as HCV-RNA above the lower limit of detection) or co-infection with Hepatitis B and C;\n* Presence of any active autoimmune disease or history thereof (including but not limited to autoimmune hepatitis, enteritis, vasculitis, nephritis; subjects requiring bronchodilator therapy for asthma are excluded); however, subjects with vitiligo, psoriasis, alopecia not requiring systemic treatment, or well-controlled Type 1 diabetes are allowed;\n* Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; active infection requiring systemic antibiotics within 2 weeks prior to the first dose (CTCAE Grade ≥2); fever \\>38.5°C of unknown origin during screening\u002Fprior to first dose (fever due to tumor progression judged by the investigator is allowed); evidence of active tuberculosis infection within 1 year prior to dosing.\n\n  12\\. Major surgery within 28 days prior to the first dose (diagnostic tissue biopsy, PICC line placement, or PORT placement are allowed).\n\n  13\\. Prior allogeneic bone marrow transplantation or solid organ transplantation.\n\n  14\\. History of substance abuse or psychiatric disorders that cannot be controlled or withdrawn.\n\n  15\\. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation.\n\n  16\\. Currently participating in another interventional clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.\n\n  17\\. Pregnant or lactating women. 18. Any other condition that, in the investigator's judgment, would compromise the subject's safety, hinder compliance, or necessitate premature study termination (e.g., severe concomitant illness, alcoholism, drug abuse, or social\u002Ffamilial circumstances).","75 Years",{"count":65,"type":22},39,[67],"PHASE2","This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1), EGFR-overexpressing non-small cell lung cancer (NSCLC).\n\nStudy Population:\n\nThe study targets patients with driver gene-negative (EGFR, ALK, ROS1, and other actionable targets) non-squamous and squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory. Additionally, eligible patients must have an immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher, be previously untreated with systemic therapy for stage IV NSCLC, have measurable lesions, show no active central nervous system metastases or uncontrolled autoimmune diseases, and voluntarily sign the informed consent form.\n\nTreatment Regimen:\n\nSubjects meeting the inclusion\u002Fexclusion criteria will receive the following treatment regimen:\n\nPucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg\u002Fkg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).\n\nBecotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg\u002Fkg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).\n\nRadiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Radiotherapy options are as follows:\n\nTarget Volume: Radiotherapy commences 2 weeks (±7 days) after the completion of Cycle 4 treatment, targeting only the primary tumor or specific 1-2 metastatic lesions.\n\nFractionation and Dosage:\n\nConventional Fractionation Group: Applicable for larger target volumes (\\>5 cm diameter) or involvement of mediastinal lymph nodes. Total dose: 45-60 Gy; single fraction dose: 1.8-2.0 Gy; administered once daily (Qd).\n\nStereotactic Body Radiotherapy (SBRT) Group: Applicable for oligometastatic lesions (≤3 lesions, each ≤3 cm diameter). Total dose: 30-50 Gy delivered in 3-5 fractions; single fraction dose: 6-10 Gy.\n\nMaintenance Therapy: Pucotenlimab (HX008) monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.",[32],[71,72,73,74],"Becotatug vedotin","Pucotenlimab","Sequential radiotherapy","Driver gene-negative NSCLC","NOT_YET_RECRUITING","2026-06-01",{"date":78,"type":46},"2026-06-04",{"date":80,"type":22},"2026-07-15",{"date":82,"type":22},"2029-07-16",{"name":84,"class":85},"Anhui Provincial Cancer Hospital","OTHER",1,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":86},"100639125","phase-2-a-clinical-study-of-sctb41-combined-with-docetaxel-in-patients-with-previously-treated-locally-advanced-or-metastatic-non-small-cell-lung-cancerphase-ii-study-ongoing-100639125","NCT07609251","A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）","A Phase II\u002FIII Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. ECOG 0-1;\n3. Survival duration more than 3 months;\n4. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent\u002Fsequential chemoradiotherapy;\n5. Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1\u002FVEGF bispecific antibody and\u002For TROP-2 ADC;\n6. At least one measurable non-brain lesion according to RECIST v1.1;\n7. Adequate major organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed presence of small cell carcinoma components;\n2. Prior treatment with docetaxel;\n3. Symptomatic central nervous system (CNS) metastases;\n4. Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;\n5. Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;\n6. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;\n7. Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;\n8. Bleeding tendency, high risk of bleeding, or coagulation disorders;\n9. Diagnosis of another malignancy;\n10. Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;\n11. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n12. History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;\n13. Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;\n15. Pregnant or breastfeeding women;\n16. Any other condition that the investigator considers inappropriate for enrollment.",{"count":95,"type":22},90,[67],"This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.",[32],"2026-05-19",{"date":101,"type":46},"2026-05-27",{"date":103,"type":22},"2026-05",{"date":105,"type":22},"2029-07",{"name":107,"class":53},"Sinocelltech Ltd.",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100640597","phase-2-phase-ii-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-alk202-for-injection-in-combination-with-drugs-in-nsclc-participants-100640597","NCT07603791","Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.","An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.","Inclusion Criteria:\n\n1. The trial Participants themselves (and\u002For guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;\n2. Men and women ≥18 and ≤75 years old on the day of signing the ICF;\n3. The trial participants agree to provide fresh or archived tumor tissues for the detection of the expression status of driving genes or proteins (such as EGFR expression, c-MET expression, and PD-L1 expression status, etc.). If the trial participants are unable to provide the required tumor tissues for testing, their participation in the trial must be approved by the sponsor;\n4. The presence of at least one measurable lesion is required according to the RECIST v1.1 criteria. A neoplastic lesion that has received local treatment, such as radiotherapy, can be taken as a target lesion if disease progression is proved by imaging;\n5. Expected survival ≥ 3 months;\n\nExclusion Criteria:\n\n1. Previously received EGFR- and\u002For MET-targeting ADCs and\u002For ADCs with topoisomerase I inhibitor as the payload;\n2. Participated in other interventional clinical trials within 4 weeks or 5 drug half-lives before the first dose of ALK202 (whichever is shorter). Note: Patients who have participated in another interventional clinical trial, even if they are still in the survival follow-up period of the previous trial, may be enrolled in this study provided that the first dose of ALK202 is to be administered ≥5 half-lives or 4 weeks from the last dose of the trial drug (whichever is shorter);\n3. Received chemotherapy, targeted therapy, immunotherapy, interventional procedure, or other systemic antitumor therapy within 4 weeks (Note: 6 weeks for nitrosourea or mitomycin C, 2 weeks or 5 half-lives of the drugs \\[whichever is shorter\\] for oral fluorouracil and small-molecule targeted drugs, and 2 weeks for Chinese medicines with anti-tumor indications) prior to the first dose of ALK202;\n4. Received radical radiotherapy, whole-brain radiotherapy, or bone marrow irradiation \\> 30% within 4 weeks before the first dose of ALK202; or palliative radiation (including stereotactic radiotherapy) of non-target lesions for symptom relief purposes within 2 weeks prior to the first dose;\n5. Took drugs or food that strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4 within 2 weeks or within 5 half-lives prior to the first dose of ALK202, whichever is longer.",{"count":116,"type":22},252,[67],"This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).\n\nPhase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.\n\nThe Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.\n\nThe Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.\n\nThe Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.\n\nPhase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.\n\nExtension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression \\\u003C 1% and high c-MET expression that has not received systemic treatment.",[32],[30],"2026-05-17",{"date":123,"type":46},"2026-05-22",{"date":125,"type":22},"2026-06-30",{"date":127,"type":22},"2028-12-30",{"name":129,"class":53},"Shanghai Allink Biotherapeutics Co., Ltd.",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":149,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100599484","phase-1-a-first-in-human-study-of-alx2004-with-advanced-or-metastatic-selected-solid-tumors-100599484","NCT07085091","A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors","Inclusion Criteria:\n\n* Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent\n\n  1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced\u002Fmetastatic setting and for whom no approved or standard therapy is available.\n  2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.\n\nHNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting\n\nNSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting\n\nESCC - Received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting\n\nCRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting.\n\n* Adequate Bone Marrow Function\n* Adequate Renal \\& Liver Function\n* Adequate Performance Status\n\nExclusion Criteria:\n\n* Participants with disease suitable for local therapy with curative intent.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator\n* Prior treatment with any ADCs that have an active TOP1 inhibitor-based component",{"count":138,"type":22},170,[140],"PHASE1","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors",[32,143,144,145,146,147,148],"HNSCC","CRC (Colorectal Cancer)","ESCC","Colo-rectal Cancer","Head and Neck Cancer","Esophageal Squamous Cell Carcinoma (ESCC)",[150,151,152,153,154,155,143,156,157,158,159,160],"ALX2004","EGFR","Solid Tumors","metastatic","Antibody Drug Conjugate","ADC","CRC","Lung","Non small cell lung cancer","esophageal","EGFR ADC","2026-05-11",{"date":163,"type":46},"2026-05-12",{"date":165,"type":46},"2025-08-18",{"date":167,"type":22},"2027-12",{"name":169,"class":53},"ALX Oncology Inc.",8,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100636288","phase-1-a-2-part-phase-12-open-label-trial-on-odm-212-100636288","NCT07563738","A 2-part Phase 1\u002F2 Open-label Trial on ODM-212","A 2-part Phase 1\u002F2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours","TEADCO","Inclusion Criteria:\n\n* Male or female participants ≥18 years old.\n* Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Life expectancy of \\>12 weeks, in the opinion of the investigator.\n* Ability to take oral medications and willing to record daily adherence to investigational product.\n* Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator.\n\n  * Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab\u002Fnivolumab; participants must not have undergone surgical therapy for mesothelioma.\n  * Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine.\n  * Arm C: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who have received the available 1st line treatment and who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.\n\nPart 2:\n\n* Ipilimumab\u002Fnivolumab cohort: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive a treatment with ipilimumab\u002Fnivolumab. Prior treatment with ipilimumab, nivolumab and\u002For other PD-1\u002FPD-L1\u002FCTLA-4 inhibitors for advanced or metastatic disease is not allowed.\n* Nab-paclitaxel\u002Fgemcitabine cohort: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive a treatment with nab-paclitaxel and gemcitabine. Previous treatments with nab-paclitaxel and\u002For gemcitabine for metastatic disease are not allowed.\n* Sotorasib cohort, treatment naïve: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.\n* Sotorasib cohort, pretreated: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C mutation, confirmed using a validated test, who have documented progression on a prior KRAS G12C inhibitor (approved or investigational).\n\n  * Part 2 only: Participants must have measurable disease by response evaluation criteria in solid tumours (RECIST) v. 1.1 (modified RECIST for MPM).\n  * A recent (taken up to 1 year ago), representative tumour tissue sample (from primary tumour or from metastasis) must be available. Tissue must be a core needle biopsy, excisional or incisional biopsy. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumour samples are also not acceptable.\n  * Amenable for paired fresh tumour biopsy at screening period and on-treatment.\n\nExclusion Criteria:\n\n* Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants has completed curative therapy.\n* Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment administration.\n* Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Ongoing adjuvant treatments for previous cancers are allowed as concomitant treatments if they do not have direct anti-tumour effect on the index tumour (e.g. hormone-suppressing agents).\n* Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared sufficiently from the participant's body before trial treatment administration.\n* Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy.\n* Any severe active infection within 1 week of trial enrolment.\n* Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive of HIV, HBV or HCV infection.\n* Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).\n* Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \\>10 mg\u002Fday prednisone or equivalent) within 2 days before trial treatment administration.\n* Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.\n* Use of other investigational medicinal products within 2 weeks or at least 5 half-lives (whichever is longer) before trial treatment administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the participant, if taking part in the trial. For drugs such as investigational monoclonal antibodies with half-lives \\>10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with trial treatments may commence.\n* Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, shingles, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.\n* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 ms, a prolonged QTc interval (QTcF\u002FB \\>470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of drugs that prolong the QT interval and are clearly associated with a known risk of torsade de pointes, even when taken as recommended per Crediblemeds.org QTdrugs list.\n* Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) \\\u003C50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of trial treatment.\n* Female participants who are breastfeeding or pregnant at screening or baseline. A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.",{"count":180,"type":22},229,[140,67],"An open-label, multi-site, multi-cohort phase 1\u002F2 trial to be conducted in 2 parts (dose escalation and dose expansion\u002Foptimisation)",[184,185,32],"Mesothelioma","Pancreatic Cancer","2026-04-29",{"date":188,"type":46},"2026-05-04",{"date":190,"type":46},"2026-03-27",{"date":192,"type":22},"2029-09",{"name":194,"class":53},"Orion Corporation, Orion Pharma",2,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":86},"100636028","phase-3-adebrelimab-combined-with-chemoradiotherapy-in-patients-with-large-bulky-stage-iii-unresectable-non-small-cell-lung-cancer-100636028","NCT07560358","Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer","A Randomized Controlled Clinical Study of Adebrelimab Combined With Chemoradiotherapy in Patients With Large Bulky Stage III Unresectable Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Aged between 18 and 75 years;\n* ECOG performance status score of 0 or 1;\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);\n* Unresectable stage III NSCLC (per AJCC 9th edition staging), with primary tumor diameter T ≥ 5 cm or regional metastatic lymph node short-axis diameter N ≥ 2 cm;\n* Expected survival time of at least 3 months;\n* No prior anti-tumor treatment before enrollment, including radiotherapy, chemotherapy, surgery and targeted therapy;\n* Adequate function of major organs;\n* Female subjects must have a negative pregnancy test result and be willing to use effective contraception;\n* Subjects voluntarily participate in the study, sign the informed consent form, with good compliance and willingness to complete follow-up.\n\nExclusion Criteria:\n\n* Subjects with known positive EGFR mutation or positive ALK fusion.\n* Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma.\n* Participation in another clinical trial within 4 weeks prior to the first study dose or within 5 half-lives of the study drug, whichever is shorter.\n* Subjects who have received systemic immunosuppressive therapy within 2 weeks before the first dose, or those who are expected to require systemic immunosuppressive drugs during the study treatment period.\n* Subjects with congenital or acquired immunodeficiency, such as HIV infection; or with a history of autoimmune diseases.\n* Active hepatitis B, hepatitis C, or co-infection with both hepatitis B and hepatitis C.\n* Uncontrolled third-space effusions, such as massive pleural effusion, ascites or pericardial effusion.\n* History of other malignant tumors (other than NSCLC) within 5 years prior to screening.\n* Subjects with prior interstitial lung disease requiring hormone therapy.\n* Subjects with severe cardiovascular and cerebrovascular diseases.\n* History of severe bleeding events or arterial\u002Fvenous thromboembolic events.\n* Severe infection within 4 weeks before the first dose; evidence of active tuberculosis infection within 1 year prior to the first dose; active fungal, bacterial and\u002For viral infections requiring systemic treatment.\n* Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation.\n* History of live attenuated vaccination within 28 days before the first dose, or planned live attenuated vaccination during the study period; pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptive measures.\n* Known hypersensitivity, anaphylactic reaction or intolerance to adebrelimab, chemotherapy agents, or their excipients.\n* Subjects with a known history of psychoactive substance abuse, alcoholism or drug addiction.",{"count":204,"type":22},204,[25],"This is a randomized, controlled, multicenter clinical study that enrolled patients with unresectable bulky stage III NSCLC, with PFS as the primary endpoint. The study aims to investigate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of locally advanced\u002Funresectable stage III non-small cell lung cancer.",[32],"2026-04-24",{"date":210,"type":46},"2026-05-01",{"date":210,"type":22},{"date":213,"type":22},"2030-12-31",{"name":215,"class":85},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":5},"100570348","phase-1-a-study-of-bh-30643-in-subjects-with-locally-advanced-or-metastatic-nsclc-harboring-egfr-andor-her2-mutations-100570348","NCT06706076","A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations","A Phase 1\u002F2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and\u002For HER2 Mutations (SOLARA)","SOLARA","Inclusion Criteria:\n\n* ≥ 18 years or legal adult.\n* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.\n* Had received standard therapies.\n* Has at least 1 measurable target extracranial lesion according to RECIST v1.1.\n* Eastern Cooperative Oncology Group Performance Status ≤ 1.\n* Has a life expectancy of ≥ 3 months.\n* Has adequate hematologic, hepatic, and renal function. \\*The above are a summary; other Inclusion Criteria details may apply.\n\nExclusion Criteria:\n\n* History of any concurrent malignancy within the previous 2 years.\n* Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).\n* Unresolved toxicities from prior therapies.\n* Any significant and uncontrolled medical condition, such as infection.\n* History of interstitial lung disease from any cause\n* Clinically significant cardiovascular event within 6 months or significant history of major organ.\n* Actively receiving investigational therapy(ies) in another clinical study. \\*The above are a summary; other Exclusion Criteria details may apply.",{"count":225,"type":22},266,[140,67],"This Phase1\u002F2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and\u002For HER2 mutations.\n\nPhase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.\n\nPhase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR\u002FHER2 mutation subtypes and\u002For treatment history at the RP2D, as well as the population PK.",[32],[30,230,231,232,233,234,235,236,237,238,239,240,241,242,151,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268],"Locally Advanced NSCLC","Metastatic NSCLC","Non-small Cell Lung Cancer","HER2 mutation","EGFR mutation","EGFR classical mutation","EGFR atypical mutation","EGFR exon20 insertion","EGFR uncommon mutation","EGFR resistant mutation","BH-30643","Tyrosine kinase inhibitor","TKI","OMNI-EGFR","EGFR kinase domain mutations","EGFR common mutation","EGFR activating mutation","Ex19del","EGFR del E746_A750","Exon 19 deletion","L858R","C797S","C797G","C797X","T790M","G719X","G724X","L718V","L718X","L861Q","S768I","S768X","E709X","L747X","Exon 19 insertion","L833X","L861X","V769X","V834X","2026-04-22",{"date":208,"type":46},{"date":272,"type":46},"2025-01-09",{"date":274,"type":22},"2029-07-31",{"name":276,"class":53},"BlossomHill Therapeutics",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":195},"100635605","phase-2-gfh375-monotherapy-and-combination-therapy-as-first-line-treatment-for-advanced-kras-g12d-mutant-non-small-cell-lung-cancer-100635605","NCT07554859","GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer","A Multicenter, Open-label, Randomized Clinical Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of GFH375 Monotherapy and Combination Therapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer Harboring KRAS G12D Mutation.","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign the written informed consent form.\n2. Male or female, aged 18 to 75 years at the time of signing the informed consent form.\n3. Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that is not amenable to radical surgery or radiotherapy.\n4. Have a written report confirming KRAS G12D mutation positive.\n5. Able to provide an archival tumor tissue sample \\[formalin-fixed, paraffin-embedded (FFPE) block or unstained FFPE tumor sections\\] or to undergo a tumor biopsy prior to treatment.\n6. No prior systemic anti-tumor therapy for advanced disease; or not eligible for standard of care therapy; or in the investigator's judgment, may benefit more from GFH375 monotherapy or combination therapy than from available standard therapy.\n7. Have at least one measurable lesion outside the central nervous system (CNS) per RECIST v1.1. Lesions that have received prior local radiotherapy can be considered measurable only if they have demonstrated clear progression after radiotherapy; otherwise, they are not considered measurable.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n\n9.Life expectancy of at least 3 months as assessed by the investigator. 10.Adequate organ function.\n\nExclusion Criteria:\n\n1. Has had another invasive malignancy that progressed or required treatment within 3 years prior to randomization, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, squamous cell carcinoma in situ, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.\n2. Pathologically (histologically or cytologically) confirmed squamous cell lung cancer, adenosquamous carcinoma, neuroendocrine carcinoma (including small cell lung cancer and large cell neuroendocrine carcinoma), or mixed small cell lung cancer.\n3. Known to harbor other targetable driver gene alterations.\n4. Has active or symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression.\n5. Has clinically significant severe cardiovascular disease.\n6. Has had a stroke or other serious cerebrovascular event within 6 months prior to randomization.\n7. Has a history of deep vein thrombosis or other severe thromboembolism within 3 months prior to randomization.\n8. Has pleural effusion, ascites, or pericardial effusion requiring frequent drainage (≥2 times per month) or associated with moderate to severe symptoms.\n9. Has clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.\n10. At high risk of gastrointestinal bleeding or perforation.\n11. Has pyloric obstruction, persistent or recurrent vomiting (≥3 episodes within 24 hours); is unable or unwilling to swallow tablets; or has other impaired gastrointestinal function or gastrointestinal disease that may significantly affect the absorption of GFH375.\n12. History of chronic diarrhea.\n13. Has a major acute or chronic infectious disease.\n14. Has other uncontrolled systemic medical conditions.\n15. Planned major surgery as determined by the investigator.\n16. History of organ transplantation or preparing to undergo organ transplantation (except corneal transplantation).\n17. Known allergy to the investigational drug or its components.\n18. Received or planned to receive a live attenuated vaccine within 28 days prior to randomization or during the administration of the investigational drug.\n19. Having severe mental or psychological disorders, a history of substance abuse, or a history of severe alcoholism.\n20. Pregnant or breastfeeding women.\n21. Other conditions deemed by the investigator to be inappropriate for participation in the study.",{"count":95,"type":22},[67],"This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).Every cohort will recruit 30 participants.",[32],[289],"KRAS G12D Mutations","2026-04-21",{"date":292,"type":46},"2026-04-28",{"date":294,"type":22},"2026-05-20",{"date":296,"type":22},"2028-04-30",{"name":298,"class":53},"Genfleet Therapeutics (Shanghai) Inc.",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":319,"locationsCount":4},"100635368","phase-1-allogeneic-nk-cell-therapy-combined-with-standard-maintenance-treatment-in-advanced-solid-tumors-100635368","NCT07551778","Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic NK Cell Injection Combined With Standard Maintenance Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age 18-75 years, either gender\n2. Cohort 1 \\& 3: Histologically or cytologically confirmed locally advanced unresectable or metastatic non-squamous NSCLC (Stage IIIB-IV) without known actionable driver gene mutations (including but not limited to: EGFR sensitizing mutations, ALK rearrangement, ROS1 rearrangement, BRAF V600E mutation, KRAS mutation)\n3. Cohort 1 \\& 3: Previously received 4-6 cycles of first-line induction therapy with PD-(L)1 inhibitor combined with pemetrexed plus platinum, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)\n4. Cohort 2: Histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma (unresectable Stage III or Stage IV per AJCC 8th edition)\n5. Cohort 2: Previously received 6-9 cycles of first-line induction therapy with cetuximab or bevacizumab combined with FOLFOX or FOLFIRI, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)\n6. Prior neoadjuvant\u002Fadjuvant chemotherapy allowed if disease recurrence or metastasis occurred \\>6 months after last chemotherapy dose\n7. At least one measurable lesion per RECIST 1.1 (except patients who achieved CR during induction therapy): non-lymph node lesion ≥1.0 cm in longest diameter, or lymph node lesion ≥1.5 cm in short diameter; lesions treated with local therapy (radiation or interventional) cannot be target lesions unless progression is documented\n8. Adequate bone marrow and organ function:\n\n   1. ANC ≥1.5×10⁹\u002FL; Platelet \\>90×10⁹\u002FL; Hemoglobin \\>9 g\u002FdL\n   2. Liver function: Total bilirubin \\\u003C1.5×ULN; ALT and AST \\\u003C3×ULN (\\\u003C5×ULN if liver metastases present)\n   3. Renal function: Serum creatinine ≤1.5×ULN\n   4. Coagulation: PT, APTT, INR \\\u003C1.5×ULN\n9. ECOG performance status 0-1\n10. Life expectancy ≥3 months\n11. Non-pregnant, non-lactating; women of childbearing potential must have negative serum pregnancy test within 7 days before cell infusion and agree to use reliable contraception during study and for 6 months after last infusion; men with partners of childbearing potential must agree to use reliable contraception\n12. Voluntary informed consent and able to comply with follow-up\n\nExclusion Criteria:\n\n1. Prior treatment with other cellular therapy products (DC, CIK, T cells, NK cells, CAR-T, etc.) except this product\n2. Other malignancies within 5 years before screening (completely resolved carcinoma in situ and slowly progressing malignancies as determined by investigator excluded)\n3. Symptomatic moderate to severe third-space effusion requiring therapeutic drainage\n4. Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months\n5. Significant cardiovascular disease history including\n6. Arterial or venous thrombotic events within 6 months before enrollment (CVA, DVT, PE, etc.)\n7. Active infection (viral, bacterial, fungal) currently being treated, or any infection requiring IV antibiotics for ≥7 days within past 6 weeks, or oral antibiotics within past 1 week\n8. Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppression\n9. Participation in other interventional clinical trials within 3 months\n10. Toxicities from prior interventions not resolved to Grade ≤2 (alopecia excluded)\n11. Untreated chronic active hepatitis B, chronic HBV carriers with HBV DNA ≥1000 copies\u002FmL; HCV antibody positive with HCV-RNA positive; HIV antibody positive; syphilis antibody positive\n12. Any other condition deemed by investigator to make subject unsuitable for study participation",{"count":307,"type":22},20,[140,67],"This is a prospective, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of allogeneic natural killer (NK) cell injection combined with standard maintenance therapy in patients with locally advanced or metastatic solid tumors. The study consists of three cohorts: Cohort 1 (advanced non-squamous NSCLC with NK cells + PD-(L)1 inhibitor + pemetrexed), Cohort 2 (advanced colorectal adenocarcinoma with NK cells + cetuximab\u002Fbevacizumab + capecitabine), and Cohort 3 (lymphodepletion exploration cohort with fludarabine + cyclophosph preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed).",[32,311,312],"Colorectal Cancer","Advanced Solid Tumors","2026-04-20",{"date":315,"type":46},"2026-04-27",{"date":103,"type":22},{"date":318,"type":22},"2029-04",{"name":320,"class":53},"BOE Technology Group Co., Ltd.",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":345,"locationsCount":347},"100605128","phase-2-overcoming-resistance-to-immunotherapy-combining-gemcitabine-with-ivonescimab-in-advanced-nsclc-100605128","NCT07158489","Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC","Protocol SAKK 18\u002F 25 Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC Progressing on Immune Checkpoint Inhibitors: A Multicenter, Single-arm, Open-label Phase II Trial (ORIGIN2)","ORIGIN2","Inclusion Criteria:\n\n* Patients fulfilling all of the following inclusion criteria are eligible for the trial:\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures including patient screening.\n* Confirmed squamous or non-squamous mNSCLC stage IIIB-IV (based on 9th edition Tumor-Node-Metastasis (TNM) classification of lung cancers with disease recurrence or progression during or after one or more prior immunotherapy or CIT regimens for metastatic disease.\n* Patients with treated and stable central nervous system (CNS) metastases are eligible, if:\n\n  * Previous CNS-directed therapy has been completed at least 4 weeks prior to treatment start.\n  * No evidence of progression after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging with Magnetic Resonance Imaging (MRI) or CT.25\n* Patients with known HIV-infection are eligible, if:\n\n  * CD4+ T-cell counts are ≥ 350 cells\u002Fµl\n  * No history of AIDS-defining opportunistic infection within past 12 months\n  * Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, or is on ART for ˃ 4 weeks and has a HIV viral load ˂ 400 copies\u002Fml.26\n* Patients with a previously treated malignancy are eligible if this is clinically stable and does not require concurrent tumor-directed treatment.\n\nException: patients suffering from prostate cancer under hormonal ablation therapy (hormone sensitive disease).\n\n* Patients with measurable disease according to RECIST v1.1.\n* Availability of newly collected or archival (maximum 3 months) samples for TR prior to treatment initiation.\n* Age ≥ 18 years\n* ECOG performance status 0-2.\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109\u002Fl, platelet count ≥ 100 x 109\u002Fl, hemoglobin ≥ 90 g\u002Fl.\n\n6.1.11 Adequate hepatic function: total bilirubin ≤ 1.5 x upper limit of normal (\\[ULN\\]; except for patients with Gilbert's disease ≤ 3.0 x ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN for patients with hepatic metastasis.\n\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\u002F1.73 m2 (according to the Chronic Kidney Disease Epidemiology Collaboration) abbreviated formula CKD-EPI formula.\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug . A negative serum or urine pregnancy test before starting trial treatment is required for all women of childbearing potential.\n* Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last administration of investigational drug.\n* Patients give their consent to participate in TR projects and providing the mandatory samples.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Prior treatment with gemcitabine in combination with immunotherapies.\n* Tumor progression within the first 8 weeks from start of first-line treatment.\n* Activating EGFR or ALK mutations.\n* Concomitant use of other anti-cancer drugs or radiotherapy.\n* Major surgery within 1 month prior to treatment start.\n* Known history of any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.\n* Known history of tuberculosis, primary immunodeficiency, allogeneic tissue\u002Fsolid organ transplant, or receipt of live attenuated vaccine.\n* History of interstitial lung disease or severe pneumonitis.\n* Concomitant use of corticosteroids as premedication for gemcitabine therapy.\n* Concomitant or prior use of immunosuppressive medication such as interferon or methotrexate within 28 days prior to trial treatment start, with the exceptions of local (i.e., intranasal, inhaled and topical) corticosteroids.\n* Major blood vessel tumor invasion.\n* Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.\n* Unstable angina, myocardial infarction, congestive heart failure (NYHA classification Grade ≥2;27) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.\n* History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment initiation.\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to study treatment initiation.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or to the Investigator's Brochure (IB).\n* Known or suspected hypersensitivity to gemcitabine or ivonescimab or to any component of the trial drugs.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to registration, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\nNote: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n\n* Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed).\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to registration is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time is within therapeutic limits according to the medical standard of the enrolling institution.\n\n  * Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic pressure ≥ 100 mmHg after oral antihypertensive therapy.\n  * Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to registration, however the following will be allowed:\n* Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n\n  * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by NCI CTCAE v5.0.\n  * Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.\n\nNote: Patients managed with indwelling catheters (e.g., PleurX) are allowed.\n\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":330,"type":22},47,[67],"This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1\u002FVEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.",[30,32],[335,336,337,338,339,340],"advanced NSCLC","immune checkpoint inhibitors","Resistance to immunotherapy","Gemcitabine and Ivonescimab","Gemcitabine","Ivonescimab",{"date":290,"type":46},{"date":343,"type":22},"2026-07",{"date":274,"type":22},{"name":346,"class":85},"Swiss Cancer Institute",7,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":368,"locationsCount":86},"100592385","phase-2-trilaciclib-in-patients-receiving-sacituzumab-tirumotecan-for-egfr-mutated-advanced-non-small-cell-lung-cancer-nsclc-100592385","NCT06992739","Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)","A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）","PROTECT-2","Inclusion Criteria:\n\n1. Age range: 18-75 years old; No gender restrictions;\n2. ECOG PS score 0-1;\n3. Expected survival time ≥ 3 months;\n4. Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have failed third-generation EGFR-TKI treatment and have experienced up to second-line EGFR-TKI treatment failure;\n\n   1. Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment;\n   2. If patients receive third-generation EGFR-TKI during neoadjuvant and\u002For postoperative adjuvant therapy and progress to metastatic or locally advanced disease more than 6 months after the last dose, they need to receive third-generation EGFR-TKI treatment again before they can participate in this study;\n   3. If patients receive third-generation EGFR-TKI during neoadjuvant and\u002For postoperative adjuvant therapy and progress to metastatic or locally advanced disease within 6 months after the last dose, they can directly participate in this study;\n   4. Imaging disease progression was recorded during or after the recent first-line treatment process.\n5. There must be at least one measurable lesion that meets the RECIST 1.1 criteria;\n6. The main organ functions well and meets the following standards:\n\n   Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 80 × 109\u002FL; Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3×ULN）； Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL\u002Fmin; Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;\n7. The subject must recover from all toxic reactions (except hair loss) of previous treatment to ≤ level 1 (evaluated based on CTCAE 5.0 criteria);\n8. Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose;\n9. Participants voluntarily participate in this study, understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;\n2. Symptomatic CNS metastases and\u002For leptomeningeal diseases that require immediate radiotherapy or steroid treatment;\n3. Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;\n4. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n5. History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases (such as claudication, Leo Buerger's disease).\n6. Patients who have received hematopoietic stem cell or bone marrow transplantation in the past;\n7. Patients who need to receive radiation therapy at the same time;\n8. Those who are known to have a history of allergies to the components of this drug regimen;\n9. Pregnant or lactating women;\n10. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.",{"count":357,"type":22},49,[67],"This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.\n\nPatients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs.\n\nRecord the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest).\n\nAfter the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET\u002FCT imaging for exploratory analysis.",[32,151,361],"Myelosuppression","2026-04-09",{"date":364,"type":46},"2026-04-14",{"date":366,"type":46},"2025-12-08",{"date":167,"type":22},{"name":369,"class":85},"The First Affiliated Hospital of Xiamen University",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":86},"100633560","phase-2-microwave-ablation-plus-tislelizumab-and-docetaxel-in-advanced-nsclc-after-first-line-immunotherapy-failure-100633560","NCT07528274","Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure","Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n* Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.\n* Male or female patients aged ≥18 years who have provided written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.\n* Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.\n* Adequate organ and bone marrow function, defined as follows:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥90 g\u002FL White blood cell count ≥3.0 × 10⁹\u002FL\n\nHepatic function:\n\nTotal bilirubin \\\u003C1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST\u002FSGOT), alanine aminotransferase (ALT\u002FSGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and\u002For bone metastases: ALP ≤5.0 × ULN\n\nRenal function:\n\nSerum creatinine ≤1.5 × ULN Urine protein \\\u003C2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required\n\nCoagulation function:\n\nInternational normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\n* Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.\n* Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n* Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.\n* Presence of symptomatic brain metastases at the start of treatment.\n* Concurrent participation in another interventional clinical trial for cancer treatment.\n* History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.\n* Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\nCerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \\>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \\>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum\u002Fplasma potassium \\\u003C LLN; magnesium \\\u003C LLN; calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.\n\n* Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.\n* Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and\u002For history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).\n* Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).\n* Known or suspected hypersensitivity to tislelizumab and\u002For any of its excipients.\n* Pregnant or breastfeeding women.\n* Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.\n* Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.",{"count":307,"type":22},[67],"The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy.\n\nParticipants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments:\n\n1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)\n2. Docetaxel: 75 mg\u002Fm² administered intravenously every 3 weeks (Q3W) for 4-6 cycles\n3. Microwave ablation, administered per protocol",[28,32],"2026-04-07",{"date":364,"type":46},{"date":210,"type":22},{"date":385,"type":22},"2028-12-31",{"name":387,"class":85},"Tianjin Medical University Cancer Institute and Hospital",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":86},"100619772","pulsatile-high-dose-furmonertinib-in-egfr-mutant-nsclc-with-leptomeningeal-metastasis-100619772","NCT07348965","Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis","Inclusion Criteria:\n\n1. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological or cytopathological examination\n2. Patients with EGFR exon 19 deletion or exon 21 L858R mutation\n3. Patients with leptomeningeal metastasis (LMD) confirmed by positive cerebrospinal fluid (CSF) cytology (within 28 days prior to the first dose administration) and with at least 1 LMD lesion that can be repeatedly evaluated by magnetic resonance imaging (MRI)\n4. Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment\n5. Aged ≥18 years and ≤85 years, with no gender restrictions.\n6. Sufficient organ function, defined as: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 75×10⁹\u002FL, hemoglobin ≥ 90g\u002FL total bilirubin ≤ 1.5×upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, total bilirubin can be relaxed to ≤ 3×ULN, and ALT\u002FAST can be relaxed to ≤ 5×ULN) serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n7. For patients enrolled in the pharmacokinetic study: no prior treatment with furmonertinib (either in combination or as monotherapy)\n8. Patients who have signed the informed consent form, are willing to receive treatment under this protocol, can adhere to medication administration, and have good compliance.\n\nExclusion Criteria:\n\n1. Unable to complete the baseline assessment form\n2. Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc.\n3. Pregnant or lactating women, or those with planned pregnancy during the study or within 6 months after the study ends\n4. Presence of central nervous system complications requiring emergency neurosurgical intervention\n5. Suffering from other malignant tumors or having a history of other malignant tumors\n6. Complicated with severe brain diseases or mental illnesses that affect the patient's ability to report symptoms by themselves\n7. Individuals without legal capacity, or those for whom medical or ethical reasons affect the continuation of the study\n8. Other circumstances deemed unsuitable for participation in this study by the researcher.\n9. Patients with a severe allergic diathesis, especially those who have experienced severe drug allergies or other serious adverse reactions during previous treatment with tyrosine kinase inhibitors (TKIs).",{"count":395,"type":22},42,[397],"NA","The goal of this clinical trial is to clarify the efficacy and safety of the high-dose alternate-day furmonertinib in NSCLC with leptomeningeal metastasis. It will also explore the mechanism by which the high-dose alternate-day administration regimen enhances efficacy from a pharmacokinetic perspective, and investigate the impact of co-occurring mutations on the efficacy and prognosis of furmonertinib in the treatment of EGFR-mutant NSCLC with leptomeningeal metastasis. The main questions it aims to answer are:\n\nDoes the high-dose alternate-day administration regimen have definite efficacy? Does the high-dose alternate-day administration regimen have favorable safety? Does the high-dose alternate-day administration regimen improve efficacy by increasing the cerebrospinal fluid (CSF) concentration and CSF penetration rate of the drug? Which co-occurring mutations may affect the efficacy and prognosis of patients with EGFR-mutant NSCLC and leptomeningeal metastasis? Participants will enter Cohort A (320mg qod po) or Cohort B (160mg qd po) to receive furmonertinib based on their own willingness and the clinician's decision, until disease, progression or uncontrollable adverse reactions occur. All patients in Cohort A will undergo efficacy and safety evaluation, with some also participating in pharmacokinetic study; patients in Cohort B will only undergo pharmacokinetic study.\n\nEfficacy and safety evaluation will be conducted through imaging examinations, neurological function assessment scales, quality of life self-assessment scales, and adverse event records. Pharmacokinetic study will be carried out by detecting the plasma concentrations and CSF concentrations of furmonertinib and its active metabolites, and calculating the CSF penetration rate for evaluation.",[32,400,401,402],"Leptomeningeal Metastasis","Furmonertinib","EGFR Activating Mutation",[30,404,405,406],"furmonertinib","leptomeningeal metastasis","cerebrospinal fluid","2026-03-31",{"date":409,"type":46},"2026-04-02",{"date":411,"type":46},"2026-03-01",{"date":385,"type":22},{"name":414,"class":85},"Guangzhou University of Traditional Chinese Medicine",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100593067","phase-2-oral-pooled-fecal-microbiotherapy-maat033-concomitant-to-cemiplimab-versus-best-investigators-choice-in-patients-with-resistance-to-treatment-due-to-antibiotics-uptake-with-advanced-non-small-cell-lung-cancer-100593067","NCT07001618","Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer","A Randomized Multicenter Phase II Trial Evaluating Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab (CB) Versus Best Investigator's Choice (BIC) in Resistance to PD-1\u002FPD-L1 Blockade Due to Antibiotics (ATB) Uptake in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)","IMMUNOLIFE2","Inclusion Criteria:\n\n1. Participants who are at least 18 years of age on the day of signing informed consent,\n2. All participants must understand spoken and written national language,\n3. Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)\n4. Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.\n5. Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation.\n6. Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).\n7. Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI.\n8. There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received.\n9. A male participant must abstain from heterosexual activity or must agree to use a contraception as detailed below (or in Appendix 2 of this protocol) during the treatment period and for at least 9 months after the last dose of CB or BIC and refrain from donating sperm during this period. (In application of the new recommendations of the CTFG)\n10. A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and if at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2.\n    2. A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A WOCBP must agree to follow the contraceptive guidance in Appendix 2 or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment.\n11. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n12. Patients must be affiliated to a social security system or beneficiary of the same\n13. Have an estimated life expectancy greater than 3 months (from inclusion).\n14. Meet acceptable steroid dose thresholds (i.e., not above the acceptable threshold \\\u003C10 mg prednisone daily or equivalent) if receiving systemic steroids at physiologic doses\n15. Have measurable disease based on RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n16. Have adequate organ function as defined in the Table 1. All screening laboratory tests must be performed within 28 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Immunodeficiency or systemic steroid therapy equivalent to prednisolone \\>10mg\u002Fday or equivalent within 7 days prior to the first dose of trial treatment.\n2. Active ongoing infection requiring ATB treatment.\n3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n4. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent and that all study drug-related AEs have resolved to grade 1 or less.\n7. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n9. Has a known history of Human Immunodeficiency Virus (HIV).\n10. Has a known history of Hepatitis B virus (HBV, defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (HCV, considered active if HCV RNA is detected) infection. Note: no testing for HBV and HCV is required unless mandated by local health authority.\n11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n12. Any condition which, in the Investigator's opinion, makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol.\n13. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n14. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of treatment.\n15. Persistent toxicities related to prior treatment of grade greater than 1.\n16. Swallowing disorders which can affect the intake of the oral pooled fecal microbiotherapy (MaaT033).",{"count":424,"type":22},162,[67],"The goal of IMMUNOLIFE2 is to overcome primary resistance to immune checkpoint inhibitors (ICIs), such as pembrolizumab or nivolumab used alone or in combination with chemotherapy, observed in patients with advanced non-small cell lung cancer (NSCLC) following antibiotic exposure, which induces intestinal dysbiosis. The reintroduction of immunotherapy with Cemiplimab, combined with oral pooled fecal microbiotherapy (MaaT033), aims to restore gut microbiota and potentially reverse resistance to ICIs.\n\nThe main objective is to determine whether the combination of MaaT033 and Cemiplimab provides a superior disease control rate compared to the current best investigator's choice as comparator.\n\nPatients will be randomized to receive either:\n\n* Experimental arm: MaaT033 administered orally for one week prior to each cycle of Cemiplimab, which will be given in hospital care every 3 weeks for 6 months, followed by Cemiplimab alone thereafter;\n* Control arm: Best investigator's choice",[32],[429,430,431,432],"MAAT033","ORAL POOLED FECAL MICROBIOTHERAPY","ADVANCED NON SMALL CELL LUNG CANCER","ANTIBIOTICS INDUCED RESISTANCE","2026-03-30",{"date":435,"type":46},"2026-04-03",{"date":437,"type":46},"2025-11-17",{"date":439,"type":22},"2032-09",{"name":441,"class":85},"Gustave Roussy, Cancer Campus, Grand Paris",6,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":452,"phases":4,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":86},"100629756","a-retrospective-real-world-study-based-on-rationale-307-100629756","NCT07478809","A Retrospective Real-World Study Based on RATIONALE-307","Long-Term Efficacy and Safety Analysis of First-Line Tislelizumab in Patients With Advanced Squamous NSCLC: a Retrospective Real-World Study Based on RATIONALE-307","Inclusion Criteria:\n\n* Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion\n\nExclusion Criteria:\n\n* Patients who had a documented death before study completion in the RATIONALE-307 trial",{"count":451,"type":22},109,"OBSERVATIONAL","The study aims to retrospectively collect long-term survival data from patients who received first-line tislelizumab combined with chemotherapy in the RATIONALE-307 trial, in order to enrich the evidence on long-term benefits in advanced squamous NSCLC patients from immunotherapy and to identify patients deriving greater clinical advantage.",[32],"2026-03-23",{"date":190,"type":46},{"date":458,"type":46},"2026-02-28",{"date":460,"type":22},"2027-12-31",{"name":215,"class":85},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":474,"conditions":475,"keywords":479,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":86},"100629041","phase-4-a-clinical-trial-on-the-outcomes-of-comprehensive-enhanced-prophylaxis-management-cepm-in-chinese-patients-with-egfr-mutated-advanced-nsclc-receiving-amivantamab-based-regimens-100629041","NCT07469488","A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens","AmiCARE: A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens","AmiCARE","Inclusion Criteria:\n\n* Aged at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.\n* Participants have a confirmed diagnosis of locally advanced or metastatic EGFR-mutated NSCLC (Stage IIIB\u002FC or IV).\n* Participant \\[and\u002For their legally authorized representative where applicable\\] must sign an ICF allowing source data verification in accordance with local requirements and indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study.\n* Participants have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Participants with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed.\n* Be eligible for, and agree to comply with, the use of enhanced dermatologic management and enhanced IRR prophylaxis management during the duration of anticancer treatments with amivantamab and lazertinib, or amivantamab with chemotherapy.\n\nCohort 1 (cEGFR 1L):\n\n* EGFR mutation must be an Ex19del or Ex21 L858R substitution.\n* Participants who plan to receive Amivantamab (IV form) and Lazertinib regimen treatment based on physician's medical judgement.\n* Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.\n* Be eligible for, and agree to comply with, the use of prophylactic-dose anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of anticancer treatment (from Day 1-120) according to Chinese Society of Clinical Oncology (CSCO) guidelines.\n\nCohort 2 (cEGFR 2L):\n\n* EGFR mutation must be an Ex19del or Ex21 L858R substitution.\n* Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.\n* Participants must have progressed on or after prior therapy including an EGFR TKI for advanced or metastatic NSCLC. Amivantamab and chemotherapy will be received as a second-line treatment.\n\nCohort 3 (EGFR Ex20ins 1L):\n\n* EGFR mutation must be an EGFR Ex20ins.\n* Participants who plan to receive Amivantamab (IV form) and Chemotherapy regimen treatment based on physician's medical judgement.\n* Participant is treatment-naive and not amenable to curative therapy including surgical resection or (chemo)radiation. Adjuvant or neoadjuvant therapy for is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Is currently enrolled in an interventional clinical study.\n* Any condition for which, at the investigator's discretion, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":471,"type":22},122,[473],"PHASE4","This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.",[32,476,477,478],"VTE (Venous Thromboembolism)","Rash Due to Epidermal Growth Factor Receptor Inhibitors","Infusion Reaction",[480,481,30,151],"Amivantamab","Lazertinib","2026-03-09",{"date":484,"type":46},"2026-03-13",{"date":486,"type":22},"2026-04-30",{"date":488,"type":22},"2029-12-31",{"name":490,"class":85},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":86},"100575704","phase-2-orient-31-regimen-in-combination-with-sbrt-for-egfr-mutant-metastatic-nsclc-after-first-line-third-generation-egfr-tkis-100575704","NCT06775743","ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs","ORIENT-31 Regimen (Sintilimab Plus Bevacizumab Plus Platinum-doublet Chemotherapy) in Combination With Stereotactic Radiotherapy in EGFR-mutant Metastatic Non-small Cell Lung Cancer After First-line Third-generation EGFR Tyrosine Kinase Inhibitors (ORBIT Study)","Inclusion Criteria:\n\n* ECOG performance status score of 0-1;\n* Histologically or cytologically confirmed stage IV primary non-small cell lung cancer;\n* EGFR-sensitive mutations (L858R, 19del);\n* Resistance to first-line treatment with third-generation EGFR-TKIs;\n* At least one measurable lesion;\n* Patients with brain metastases may be included, but they must be asymptomatic neurologically and have stable lesions without the need for systemic corticosteroid treatment;\n* Men and women of reproductive age agree to contraception during the trial (surgical sterilization or oral contraceptives\u002Fintrauterine device + condoms);\n* Life expectancy ≥ 3 months;\n* Within one week before enrollment, organ function levels must meet the following criteria:\n\n  1. Bone marrow function: Hemoglobin ≥ 80 g\u002FL, white blood cell count ≥ 4.0 × 10\\^9\u002FL or neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL;\n  2. Liver: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total bilirubin level \\> 1.5 times the upper limit of normal, direct bilirubin level must be ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal;\n  3. Kidney: Serum creatinine level \\\u003C 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 ml\u002Fmin, blood urea nitrogen ≤ 200 mg\u002FL; serum albumin ≥ 30 g\u002FL;\n* Patients must have the capacity to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia.\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.\n* History of other malignant tumors.\n* Patients with active infections, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmias.\n* Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases.\n* Patients whom the investigator believes currently have lesions requiring palliative radiation therapy.\n* Mixed with small cell lung cancer components.\n* Nursing or pregnant women.\n* Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation.\n* Known hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis infection.\n* Patients who have received cancer vaccines or received other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are often inactivated vaccines and are allowed, while intranasal preparations are usually live attenuated vaccines and are not allowed).\n* Patients who are concurrently using other immunotherapies, chemotherapy drugs, drugs from other clinical trials, or require long-term corticosteroid treatment are not eligible for enrollment.\n* Patients with psychiatric disorders, substance abuse, or social issues that affect compliance are not eligible for enrollment after physician review.\n* Patients who are allergic to or contraindicated for PD-1 monoclonal antibodies, VEGF monoclonal antibodies, or chemotherapy drugs.\n\nWithdrawl criteria:\n\n* Incorrectly enrolled participants. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the investigator should assess the participant's benefit-risk profile and then decide whether to withdraw. If withdrawal is necessary, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.\n* Participants who experience the following during the pre-treatment evaluation phase: new systemic diseases or worsening of existing systemic diseases that meet exclusion criteria; voluntary withdrawal, loss to follow-up, or death; poor compliance.\n* Participants whom the investigator deems necessary to exclude. The investigator must report the reason for exclusion to the principal investigator and obtain consent. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.\n* Participants may request to withdraw from the clinical trial at any time during the trial process.\n* Participants who experience serious adverse events during the trial, and whom the investigator deems should stop participating in the trial.\n* Participants whose condition worsens during the trial, potentially threatening their life, or who develop other conditions that affect trial observations.\n* Participants who are lost to follow-up or die during the treatment phase.\n* Participants who use chemotherapy, traditional Chinese medicine, other immunotherapy drugs, radiotherapy sensitizers, or other agents that affect efficacy and toxicity evaluation during the trial period.\n* Participants in whom serious deviations occur during the implementation of the clinical trial protocol, making it difficult to evaluate the drug's effect; those with poor compliance.\n\nExit criteria:\n\n* Wrong enrollees who did not meet the inclusion criteria;\n* Serious protocol violations.",{"count":499,"type":22},53,[67],"The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients who failed first-line third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Participants will first receive the standard four-drug combination therapy: PD-1 antibody + vascular endothelial growth factor (VEGF) antibody + platinum + pemetrexed. The efficacy will be evaluated every two courses. According to the efficacy evaluation results, personalized SBRT was be administered.",[32,503],"EGFR Mutation Positive Advanced Non Small Cell Lung Cancer","2026-03-08",{"date":506,"type":46},"2026-03-11",{"date":508,"type":46},"2025-01-15",{"date":510,"type":22},"2027-06",{"name":512,"class":85},"Fudan University",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":452,"phases":4,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100620355","observational-prospective-multi-centric-study-exploring-her2-mutations-incidence-and-therapeutic-management-in-ansclc-100620355","NCT07356544","Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC","HER2 in Advanced NSCLC: an Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in Italy. The HEROS Study - GOIRC-01-2022","HEROS","Inclusion Criteria:\n\nCohort 1 (Prevalence study population)\n\n1. Male or female, aged at least 18 years.\n2. Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025.\n3. Locally advanced (IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (IV) NSCLC according to TNM VIII edition.\n4. Enrolled in ATLAS project. Cohort 2 (HER2 mutations study population)\n5. Included in Cohort 1.\n6. Presence of HER2 mutation.\n7. Enrolled in ATLAS project. Cohort 3 (Prospective Biomarker Analysis population)\n8. Included in Cohort 2.\n9. Availability of tissue sample from the first 50 patients enrolled in cohort 2.\n10. Written informed consent (HEROS project) must be obtained before any study-related procedure.\n\nExclusion Criteria:\n\n\\-",{"count":522,"type":22},50,"The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.",[32,525],"HER2",[527],"HER2 mutated","2026-03-04",{"date":530,"type":46},"2026-03-05",{"date":532,"type":46},"2025-08-12",{"date":534,"type":22},"2027-01-31",{"name":536,"class":85},"Gruppo Oncologico Italiano di Ricerca Clinica",22,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":4},"100625148","phase-2-fanlung-2the-value-of-high-low-mixed-dose-radiotherapy-combined-with-chemo-immunotherapy-induction-in-locally-advanced-non-small-cell-lung-cancer-100625148","NCT07418866","FANLUNG-2：The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer","The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer - A Prospective, Open-Label, Randomized Controlled, Phase II Study (FANLUNG-2)","Inclusion Criteria:\n\n* Signed written informed consent obtained prior to the initiation of any trial-related procedures.\n* Age \\> 18 years.\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n* Negative for driver gene mutations (EGFR, ALK, ROS1, RET, MET exon 14 skipping, HER2, BRAF, KRAS G12C).\n* Locally advanced disease, including Stage III and selected Stage IV (where all lesions are deemed safely treatable with a radiotherapy dose \\> 50 Gy in 10 fractions, as assessed by a senior radiation oncologist).\n* At least one thoracic lesion with a short-axis diameter \\> 2 cm.\n* Positive hilar or mediastinal lymph nodes.\n* ECOG Performance Status of 0 or 1.\n* Life expectancy \\> 3 months.\n* Adequate organ function, as defined by the following laboratory parameters:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL.\n  2. Platelet count ≥ 100 × 10⁹\u002FL.\n  3. Hemoglobin \\> 9 g\u002FdL.\n  4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n  6. Serum creatinine ≤ 1.5 × ULN AND calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n  7. Adequate coagulation, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN.\n  8. Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within normal limits. Subjects with baseline TSH outside the normal range may be enrolled if both total T3 (or free T3) and free T4 levels are within normal limits.\n  9. Cardiac enzymes within normal limits (subjects may be enrolled if the investigator judges isolated laboratory abnormalities to be clinically insignificant).\n* For female subjects of childbearing potential, a negative urine or serum pregnancy test must be documented within 3 days prior to receiving the first dose of study medication (Cycle 1, Day 1). If a urine pregnancy test result is ambiguous or cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as being postmenopausal for at least 1 year, surgically sterile, or having undergone a hysterectomy.\n* Subjects (both male and female) at risk of pregnancy must agree to use highly effective contraception (with a failure rate of \\\u003C1% per year) throughout the treatment period and for 120 days after the last dose of study medication (or 180 days after the last dose of chemotherapy), whichever is later.\n\nExclusion Criteria:\n\n* Patients with severe emphysema, interstitial lung changes, or COPD;\n* Resting blood oxygen saturation \\\u003C 93%;\n* History of other malignancies requiring chemotherapy within the past 2 years;\n* History of thoracic radiotherapy;\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first study dose (excluding topical, nasal, inhaled, or local corticosteroids); \\*Note: Physiological corticosteroid doses (≤10 mg\u002Fday prednisone or equivalent) are permitted.\\*\n* Known history of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation;\n* Known allergy to any component of the study drug or its excipients;\n* Known history of HIV infection (positive HIV1\u002F2 antibodies);\n* Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory);\n\nNote: Hepatitis B subjects meeting the following criteria may be enrolled:\n\na) HBV DNA \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) before the first dose, with ongoing antiviral therapy throughout chemotherapy to prevent reactivation; b) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV DNA (-) do not require prophylactic antiviral therapy but require close monitoring for reactivation.\n\n* Active HCV infection (positive HCV antibody with detectable HCV-RNA above the lower limit of detection);\n* Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated seasonal influenza vaccines are permitted within 30 days prior to the first dose; live attenuated intranasal influenza vaccines are not allowed.\n* Pregnant or breastfeeding women;\n* Any severe or uncontrolled systemic disease, including but not limited to:\n\n  1. Resting ECG showing clinically significant uncontrolled abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation);\n  2. Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Class ≥2;\n  3. Arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, stroke, or transient ischemic attack);\n  4. Poorly controlled hypertension (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg);\n  5. History of non-infectious pneumonitis requiring corticosteroids within 1 year prior to the first dose, or current clinically active interstitial lung disease;\n  6. Active tuberculosis;\n  7. Active or uncontrolled infection requiring systemic therapy;\n  8. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL);\n  11. Urine dipstick showing protein ≥++ with confirmed 24-hour urine protein \\>1.0 g;\n  12. Psychiatric disorders that may interfere with treatment compliance;\n* Any other condition (e.g., medical history, disease, ongoing treatment, or laboratory abnormality) that may interfere with study results, compromise patient participation, or pose additional risks-in the investigator's judgment-making the subject unsuitable for study enrollment.",{"count":546,"type":22},70,[67],"Moving immunotherapy ahead of chemoradiotherapy in a \"sandwich\" model-where tumor reduction is achieved through induction chemo-immunotherapy, immunotherapy is paused during chemoradiotherapy, and then resumed as maintenance post-radiotherapy-has shown promising potential. However, this approach still faces two main challenges: insufficient depth of tumor response and an increased risk of radiation pneumonitis.To address these issues, we investigators have designed a novel high-low mixed-dose irradiation strategy. This approach, combined with two cycles of induction chemo-immunotherapy, aims to achieve rapid tumor regression, improve disease control rates, and reduce overall lung radiation exposure.",[32],"2026-02-11",{"date":552,"type":46},"2026-02-18",{"date":554,"type":22},"2026-02",{"date":556,"type":22},"2028-12",{"name":512,"class":85},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":195},"100589560","phase-3-firmonertinib-versus-platinum-based-chemotherapy-as-first-line-treatment-for-nsclc-with-egfr-pacc-or-egfr-l861q-mutation-100589560","NCT06956001","Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation","A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years at the time of ICF signing.\n3. At least one measurable lesion per RECIST v1.1, meeting the following:\n\n   * No prior local therapy (e.g., radiotherapy)\n   * Not used for biopsy during screening\n4. Histologically\u002Fcytologically confirmed non-squamous NSCLC, classified as:\n\n   * Locally advanced (Stage IIIB\u002FIIIC, unsuitable for curative surgery and\u002For definitive chemoradiotherapy)\n   * Metastatic (Stage IV) (Based on UICC\u002FAJCC 8th edition TNM staging)\n5. Agreement to provide:\n\n   * Recent tumor tissue (from untreated lesions)\n   * Blood samples\n   * Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)\n6. No prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   * Allowed if: Prior (neo)adjuvant\u002Fdefinitive chemoradiotherapy completed ≥12 months before recurrence\u002Fprogression\n7. ECOG performance status 0-1.\n8. Life expectancy ≥12 weeks.\n9. Adequate bone marrow\u002Forgan function within 14 days before treatment (no transfusion\u002FG-CSF within 2 weeks prior).\n10. Women of childbearing potential (WOCBP):\n\n    * Abstinence or contraception use\n    * No egg donation\n11. Non-sterilized males:\n\n    * Abstinence or contraception use\n    * No sperm donation\n12. CNS metastases allowed if protocol-specified criteria are met.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed tumor with \\>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.\n2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.\n3. Prior treatments including:\n\n   1. Systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC (e.g., chemotherapy\u002Ftargeted\u002Fimmunotherapy). Neoadjuvant\u002Fadjuvant therapy exceptions per Inclusion Criterion #6.\n   2. \\>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).\n   3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).\n   4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.\n   5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.\n   6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.\n   7. Major trauma\u002Fsurgery within 4 weeks prior to treatment initiation.\n4. Clinically significant gastrointestinal abnormalities, including:\n\n   * Moderate\u002Fsevere atrophic gastritis\n   * GI obstruction\u002Fperforation\n   * Chronic diarrhea\u002Fshort bowel syndrome\n   * Major upper GI surgery (e.g., gastrectomy)\n   * Inflammatory bowel disease (Crohn's\u002Fulcerative colitis) or active intestinal inflammation\n   * Inability to swallow tablets\n5. Uncontrolled systemic diseases.\n6. Severe acute\u002Fchronic infections.\n7. Interstitial lung disease (ILD)\u002Fnon-infectious pneumonia:\n\n   * History requiring clinical intervention\n   * Current presence\n   * Suspicious imaging findings unresolved at screening\n8. Clinically significant cardiovascular dysfunction (active or history).\n9. Tumor invasion of critical adjacent structures (heart\u002Fesophagus\u002FSVC etc.) with high bleeding\u002Ffistula risk. Exceptions may be considered if investigator assesses minimal risk.\n10. Pulmonary comorbidities causing severe impairment, including:\n\n    1. Baseline lung diseases (e.g., pulmonary embolism \\[≤3 months\\], severe asthma\u002FCOPD\u002Frestrictive disease)\n    2. Autoimmune\u002Fconnective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)\n11. Residual toxicity \\>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia\u002Fneuropathy).\n12. Concurrent malignancies except:\n\n    * Cured localized skin cancers (BCC\u002FSCC), superficial bladder cancer, cervical\u002Fbreast DCIS, or papillary thyroid cancer\n    * Other malignancies cured by radical therapy ≥3 years prior\n13. Pregnancy\u002Flactation or planned pregnancy within 6 months post-treatment.\n14. Inability to comply with study procedures\u002Ffollow-up.\n15. Known hypersensitivity to furmonertinib or excipients.\n16. History of allergic reactions to pemetrexed\u002Fcisplatin\u002Fcarboplatin.\n17. Other exclusionary per investigator judgment, including:\n\n    * Alcohol\u002Fdrug abuse\n    * Severe comorbidities (including psychiatric) requiring treatment\n    * Critical laboratory abnormalities\n    * Social\u002Ffamilial factors compromising safety\u002Fdata collection",{"count":566,"type":22},300,[25],"This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.\n\nEligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.",[151,32],[571],"firmonertinib","2026-02-10",{"date":574,"type":46},"2026-02-12",{"date":576,"type":46},"2024-11-19",{"date":578,"type":22},"2028-07",{"name":580,"class":53},"Allist Pharmaceuticals, Inc.",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":452,"phases":4,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":4},"100623741","anlotinib-in-cross-line-treatment-of-nsclc-and-sclc-100623741","NCT07400575","Anlotinib in Cross-line Treatment of NSCLC and SCLC","Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC","NSCLC SCLC","Inclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:\n\n* Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.\n* Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.\n* Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.\n\nExclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:\n\n* Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.\n* Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.\n* Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.\n* Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.",{"count":590,"type":22},350,"Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.\n\nThis study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.",[32,593],"SCLC, Extensive Stage",[595,596,597],"Anlotinib","mNSCLC","ES-SCLC","2026-02-03",{"date":572,"type":46},{"date":601,"type":22},"2026-02-01",{"date":460,"type":22},{"name":604,"class":605},"Henan Cancer Hospital","OTHER_GOV",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100620119","phase-2-radiotherapy-plus-anti-pd-1-versus-anti-pd-1-alone-in-yptanynm0-nsclc-100620119","NCT07353476","Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC","Postoperative Involved-field Nodal Radiotherapy Plus Anti-PD-1 Maintenance Versus Anti-PD-1 Maintenance Alone in Patients With ypTanyN⁺M0 NSCLC After Neoadjuvant Chemoimmunotherapy and R0 Resection: A Single-center Randomized Phase II Study","Inclusion Criteria:\n\n* Age 18-75 years, male or female.\n* Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, or other NSCLC subtypes).\n* Clinical stage IIIA\u002FIIIB at initial diagnosis, deemed suitable for neoadjuvant chemoimmunotherapy followed by surgery according to MDT.\n* Completed 2-4 cycles of platinum-based doublet chemotherapy plus PD-1 inhibitor as neoadjuvant therapy.\n* Underwent R0 resection (anatomical lobectomy or pneumonectomy with mediastinal lymph node dissection).\n* Postoperative pathological stage ypT\\_anyN⁺M0 (residual nodal metastasis in mediastinal or hilar lymph nodes).\n* ECOG performance status 0-1.\n* Adequate hematologic, hepatic, and renal function per protocol-defined lab thresholds.\n* Able to start postoperative radiotherapy and\u002For PD-1 maintenance within 4-10 weeks after surgery (or after recovery from postoperative complications, as clinically appropriate).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Positive surgical margins (R1 or R2) or incomplete resection.\n* Prior thoracic radiotherapy that would overlap with planned treatment fields.\n* Active, uncontrolled infection or unresolved ≥ Grade 2 immune-related adverse events.\n* History of severe autoimmune disease requiring systemic immunosuppression.\n* Uncontrolled interstitial lung disease or significant pulmonary fibrosis.\n* Symptomatic or untreated central nervous system metastases at enrollment.\n* Any condition that, in the investigator's judgment, would compromise patient safety or protocol compliance.",{"count":614,"type":22},38,[67],"Patients with stage III non-small-cell lung cancer (NSCLC) who receive neoadjuvant chemoimmunotherapy may achieve good response in the primary tumor but still have residual nodal disease after surgery (ypTanyN⁺M0), which is associated with poor prognosis in retrospective analyses from our center. In prior trials such as LungART and PORT-C, postoperative radiotherapy (PORT) did not improve disease-free survival in completely resected stage IIIA-N2 NSCLC after adjuvant chemotherapy, suggesting that PORT should not be used indiscriminately. However, recent preclinical and translational data indicate that radiotherapy can enhance antitumor immunity, remodel the tumor microenvironment, and synergize with immune checkpoint inhibitors via immunogenic cell death, improved T-cell trafficking, and tertiary lymphoid structure formation.\n\nThis single-center randomized phase II study will evaluate whether adding postoperative involved-field nodal radiotherapy to standard PD-1 maintenance therapy can improve disease-free survival compared with PD-1 maintenance alone in patients with ypTanyN⁺M0 NSCLC after neoadjuvant chemoimmunotherapy and R0 resection.",[32,618],"Post Surgical",[620,621,622],"Radiotherapy","Adjuvant therapy","Lymph node","2026-01-19",{"date":625,"type":46},"2026-01-20",{"date":76,"type":22},{"date":628,"type":22},"2032-06-01",{"name":630,"class":85},"Shanghai Zhongshan Hospital",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":646,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":657},"100621518","phase-1-an-phase-ibii-clinical-trial-of-tcc1727-combination-therapy-in-advanced-solid-tumors-100621518","NCT07371663","An Phase Ib\u002FII Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors","An Open-Label, Multicenter Phase Ib\u002FII Clinical Trial of TCC1727 in Combination With Benmelstobart\u002FOlaparib\u002FTopotecan for Advanced Solid Tumors","Inclusion Criteria:\n\n* -Voluntarily participate in this study and sign the informed consent form.\n* At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).\n* Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:\n\n  * Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.\n  * Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts):\n\nTCC1727 combined with Benmelstobart Group:\n\nThe study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):\n\nCohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.\n\nSubgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.\n\nCohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nCohort 3 (Other Advanced Solid Tumors):Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or for whom standard therapy is currently unsuitable.\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nTCC1727 combined with Olaparib Tablets Group:\n\nThe study will enroll subjects with histopathologically confirmed recurrent ovarian cancer:\n\nCohort 4 (Ovarian Cancer):Subjects with histopathologically confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:\n\nSubgroup 1: Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.\n\nSubgroup 2: Subjects who have not received Olaparib Tablets and have primary platinum-resistant\u002Frefractory disease (recurrence within 6 months of last platinum-based therapy). Subjects must have received ≤3 prior lines of therapy since developing platinum resistance.\n\nTCC1727 combined with Topotecan Hydrochloride for Injection Group:\n\nThe study will enroll subjects with histopathologically or cytologically confirmed small cell lung cancer (SCLC):\n\nCohort 5 (SCLC):Subjects who have progressed after platinum-based chemotherapy combined with PD-(L)1 therapy, or subjects with extensive-stage SCLC who have relapsed or progressed within ≤6 months after first-line therapy.\n\n* At least one measurable lesion (per RECIST v1.1; lesions previously treated with local therapy may be considered target lesions if they show clear progression per RECIST v1.1).\n* Subjects must provide sufficient tumor tissue samples, including but not limited to fresh specimens (preferred) or formalin-fixed, paraffin-embedded (FFPE) tumor tissue obtained within approximately 24 months prior to randomization, unstained FFPE slides, or core needle biopsy tissue for biomarker testing.\n* ECOG performance status score of 0-1 within 7 days prior to the first dose of study drug.\n* Expected survival ≥12 weeks.\n* Ability to swallow tablets whole and maintain this method of administration.\n* Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose):\n\n  1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n  2. White blood cell count (WBC) ≥3.0 × 10⁹\u002FL;\n  3. Platelet count ≥100 × 10⁹\u002FL;\n  4. Hemoglobin (Hb) ≥90 g\u002FL;\n  5. Serum albumin ≥30 g\u002FL;\n  6. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  7. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  8. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);\n  9. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n  10. APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy);\n  11. QTc \\\u003C450 ms (male) or \\\u003C470 ms (female), LVEF ≥50%.\n* For non-sterilized or fertile female subjects, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study and for 6 months after the last dose. Non-sterilized female subjects must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding. Male subjects with fertile partners must use effective contraception during the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and\u002For irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases \\\u003C1 cm in diameter without surrounding edema are also allowed.\n* Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \\\u003C4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed \\>5 half-lives or \\>10 days before the first dose, whichever is longer; palliative radiotherapy completed \\>2 weeks before the first dose).\n* Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).\n* Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting inclusion criteria).\n* Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).\n* Uncontrolled severe diseases, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);\n  2. Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe\u002Funstable angina, stroke, ≥Grade 2 congestive heart failure \\[NYHA classification\\]);\n  3. Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms \\[male\\] or ≥470 ms \\[female\\]);\n  4. Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;\n  5. Active viral hepatitis (HBV DNA ≥500 IU\u002FmL for HBsAg-positive and\u002For anti-HBc-positive subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV\u002FHCV-positive subjects);\n  6. Active syphilis;\n  7. Active tuberculosis;\n  8. Immunodeficiency (e.g., HIV-positive, congenital\u002Facquired immunodeficiency, organ transplant history);\n  9. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Uncontrolled pleural effusion, pericardial effusion, ascites, or recurrent ascites requiring drainage within 28 days before the first dose.\n* Significant bleeding symptoms or tendency within 3 months before the first dose.\n* Chronic systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily) or immunosuppressive therapy within 14 days before the first dose.\n* Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., immunomodulators, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency) is allowed. (Applies only to Ib Phase and Phase II TCC1727 + Benmelstobart groups.)\n* History of severe allergic reactions to study drugs or their excipients.\n* Other malignancies within 3 years before screening (except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma).\n* Prior ≥Grade 3 immune-mediated adverse events (imAEs) or permanent discontinuation due to imAEs during anti-PD-(L)1 therapy.\n* Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1\u002FCHK2 inhibitors).\n* Other severe physical\u002Fmental illnesses or factors that may increase study risk or interfere with results, or any condition deemed unsuitable by the investigator.\n\nAdditional exclusions:\n\n* Phase II Cohort 1 (NSCLC):Exclude subjects with known EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations; exclude mixed NSCLC\u002FSCLC histology.\n* Phase II Cohort 2 (Endometrial Cancer):Exclude uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.\n* Phase II Cohort 3 (Other Solid Tumors):Exclude KRAS\u002FNRAS\u002FBRAF mutations or MSI-H status.\n* Phase II Cohort 4 (Ovarian Cancer) \\& Ib Phase TCC1727 + Olaparib Tablets: Exclude prior myelodysplastic syndrome or acute myeloid leukemia.",{"count":225,"type":22},[140,67],"This is a Phase Ib\u002FII clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart \u002Folaparib \u002Ftopotecanfor patients with advanced solid tumors.\n\nThe Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart \u002Folaparib\u002Ftopotecanin selected advanced solid tumor indications.\n\nThe study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.",[642,32,643,644,645],"Solid Cancers","Gastric (Stomach) Cancer","Endometrial Cancer","Malignant Melanoma",[647,648],"Ataxia Telangiectasia and Rad3-related protein inhibitor","Advanced solid tumor",{"date":650,"type":46},"2026-01-28",{"date":652,"type":46},"2025-12-03",{"date":654,"type":22},"2029-06-30",{"name":656,"class":53},"Beijing Tide Pharmaceutical Co., Ltd",3,{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":86},"100620716","phase-1-a-phase-l-clinical-study-to-evalute-the-safetytolerabilitypharmacokinetic-characteristicsand-preliminary-anti-tumor-efficacy-of-hj-004-02-tablets-in-patients-with-non-squamous-non-small-cell-lung-cancer-with-epidermal-growth-factor-receptor-egfr-mutations-100620716","NCT07361237","A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor Efficacy of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations","HJ-004-02-101","Inclusion Criteria:\n\n1. Male or female, aged \\>=18 years and \\\u003C75 years\n2. Clinical diagnosis of NSCLC.\n3. Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.\n4. Subjects must provide 3-5 archived tumor tissue slides\n5. Subjects must have non-squamous NSCLC with one or more positive EGFR mutations\n6. At least one measurable lesion according to RECIST v1.1 (In Phase Ia, lesions that are assessable but not measurable are acceptable).\n7. ECOG performance status score of 0-1\n8. Life expectancy \\>=12 weeks.\n9. (1) Hematologic Function:Absolute neutrophil count (ANC) \\>= 1.5×10\\^9\u002FL;Platelet count (PLT) \\>= 100×10\\^9\u002FL;Hemoglobin (HGB) \\>=9.0 g\u002FdL; (2)Hepatic Function:Total bilirubin (TBIL) \\\u003C=1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) For those without liver metastases, \\\u003C=2.5 × ULN, orFor those with liver metastases, \\\u003C=5 × ULN; (3)Renal Function:Creatinine \\\u003C=1.5 × ULN; if \\>1.5 × ULN, creatinine clearance ≥50 mL\u002Fmin \\[Creatinine clearance calculated using the Cockcroft-Gault formula (see Appendix 2: Cockcroft-Gault Formula)\\] (4)Coagulation Panel Note: For subjects receiving anticoagulant therapy, the investigator will determine whether the international normalized ratio (INR) and activated partial thromboplastin time (APTT) are within a safe therapeutic range. INR \\\u003C= 1.5×ULN;APTT \\\u003C= 1.5×ULN.\n10. Contraception is required during the trial period.\n\nExclusion Criteria:\n\n1. Within the four weeks prior to the administration of HJ-004-02 tablets, the patient had received other anti-tumor treatments such as biological therapy, immunotherapy, radiotherapy, and chemotherapy.\n2. Participation in an investigational drug study with treatment or use of an investigational device within 4 weeks before the first dose of HJ-004-02 tablets. 3. Anticipated need for any other form of anti-tumor therapy during the study.\n\n4\\. Toxicity from prior therapy has not resolved to \\\u003C=Grade 1 according to NCI-CTCAE v5.0 criteria, with the exception of alopecia and long-term stable chronic disease.\n\n5\\. Presence of histological transformation, and ALK, HER2, KRAS, ROS1, FGFR, NTRK, RET, BRAF gene abnormalities in EGFR-TKI non-dependent drug resistance; 6. History of severe eye disorder prior. 7. History of severe dermatosis prior. 8. Subjects who have gastrointestinal disease 9. Subjects who have received treatment with P-gp inhibitors, potent CYP3A4 inhibitors 10. Subjects with uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage procedures, as judged by the investigator.\n\n11\\. Subjects with symptomatic brain metastasis, metastases to meninges, or spinal cord compression.\n\n12\\. Subjects with an active infection of \\>=Grade 2 13. Subjects with a history of allergy to the active ingredient or inactive excipients of HJ-004-02 tablets, or to drugs with a similar chemical structure or class to HJ-004-02 tablets.\n\n14\\. Subjects with a confirmed immunodeficiency disease, and\u002For a positive HIV test result at screening.\n\n15\\. Subjects with active hepatitis B 16. Subjects with positive syphilis antibodies and a positive titer test. 17. Active tuberculosis. 18. Presence of a malignancy other than the indication of this study within \\\u003C=5 years before the first dose of HJ-004-02 tablets 19. Subjects who have had a clinically significant cerebrovascular disorder within 6 months before the first dose of HJ-004-02 tablets, 20. Subjects who have undergone major surgery or severe traumatic injury within 4 weeks before the first dose of HJ-004-02 tablets, or who are expected to require major surgery during the study.\n\n21\\. History of interstitial lung disease (ILD) 22. Subjects with any haemorrhagic diathesis or coagulopathy 23. Subjects with a known psychiatric illness 24. Those who have received a live attenuated vaccine within 28 days before the first dose of the investigational product or plan to receive one during the study and within 60 days after the end of investigational product treatment.\n\n25\\. Female subjects who are pregnant or breastfeeding. 26. Any other condition that, in the investigator's judgment, would hinder the subject's participation in the clinical study.",{"count":666,"type":22},36,[140],"Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle.",[32],"2026-01-14",{"date":672,"type":46},"2026-01-22",{"date":674,"type":22},"2025-12-30",{"date":385,"type":22},{"name":677,"class":85},"Tongji University"]