[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-squamous-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-squamous-non-small-cell-lung-cancer":476},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,52,75,106,138,172,194,216,237,261,280,307,328,351,377,404,425,449],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100564320","phase-3-a-global-phase-iii-study-of-rilvegostomig-or-pembrolizumab-plus-chemotherapy-for-first-line-treatment-of-metastatic-non-squamous-nsclc-100564320",false,"NCT06627647","A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC","A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)","Inclusion Criteria:\n\n* Histologically or cytologically documented non-squamous NSCLC.\n* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.\n* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.\n* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.\n* Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.\n* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Presence of small cell and neuroendocrine histology components.\n* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.\n* Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and\u002For definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \\> 12 months after the end of treatment.\n* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.\n* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Active primary immunodeficiency\u002Factive infectious disease(s).\n* Active tuberculosis infection.","ALL","18 Years",{"count":19,"type":20},878,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.",[26],"Non-squamous Non-small Cell Lung Cancer",[28,29,30,31,32,33,34,35,36,37,38],"ARTEMIDE-Lung03","Rilvegostomig (AZD2936)","Non-squamous non-small cell lung cancer (NSCLC)","Bi-specific antibody","T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)","EGFR, ALK and ROS1 testing","Programmed cell death protein (PD-L1)","Pembrolizumab","Carboplatin","Cisplatin","Pemetrexed","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-29","ACTUAL",{"date":45,"type":43},"2024-11-27",{"date":47,"type":20},"2030-11-18",{"name":49,"class":50},"AstraZeneca","INDUSTRY",286,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100553882","race-2l-real-world-assessment-of-clinical-practice-and-outcomes-in-non-squamous-nsclc-after-failure-of-platinum-based-chemotherapy-in-brazil-100553882","NCT06491862","RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil","RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous Non-Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy in Brazil","RACE-2L","Inclusion Criteria\n\n* Confirmed diagnosis of patients with non-squamous NSCLC stage IIIB\u002FIIIC not eligible for curative-intent therapies or stage IV\u002FM1 (a\u002Fm NSCLC) with or without actionable genomic mutations (i.e., EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, HER-2)\n* Aged at least 18 years at first diagnosis of a\u002Fm NSCLC\n* For the AGA subgroup, having received platinum-based chemotherapy, having received at least one target approved therapy.\n* For the non\\_AGA subgroup,should have received either sequential or concurrent use of ICI and PTC)\n* Patient must have received at least line of therapy of an active agent after failing PTC.\n\nExclusion Criteria\n\n* Patients with evidence of other primary malignancies (apart from basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both the study cohorts.\n* Patients who participated in an investigational clinical trial for the treatment of any cancer, including NSCLC, or any early access program from 2018 onward.",{"count":61,"type":20},250,"OBSERVATIONAL","The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a\u002Fm non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2024.",[65],"Non-squamous Non-Small Cell Lung Cancer","2026-06-19",{"date":68,"type":43},"2026-06-23",{"date":70,"type":43},"2024-07-25",{"date":72,"type":20},"2026-06-30",{"name":49,"class":50},11,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100642069","phase-3-aglatimagene-besadenovec--prodrug-and-pembrolizumab-vs-docetaxel-for-stage-iv-non-squamous-nsclc-progressing-on-pembrolizumab-aurora-100642069","NCT07660094","Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)","A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment","LuTK03","Inclusion Criteria:\n\n1. Age ≥ 18 years, at the time of signing the informed consent.\n2. Histologically confirmed metastatic Stage IV non-squamous NSCLC.\n3. Measurable disease per RECIST v1.1 with at least 1 thoracic lesion amenable to intratumoral injection (e.g., pathological lymph node or lung lesion).\n\n   Note: Able to be reached by bronchoscopy (including robotic bronchoscopy or flexible bronchoscopy with or without endobronchial ultrasound), or by percutaneous injection.\n4. Documented radiographic progression observed in at least 3 consecutive scans or according to RECIST v1.1 criteria after a minimum of 12 weeks on continued pembrolizumab, determined by central review.\n\n   Note: Participants on a pembrolizumab-based regimen should have achieved a best overall response (BOR) of at least SD (e.g., participants with a BOR of PD while on pembrolizumab are not eligible).\n5. Prior treatment requirements:\n\n   1. Must have received platinum-based chemotherapy in any line of therapy.\n   2. May have received pembrolizumab therapy in combination with chemotherapy or sequentially. Note: The participant must be currently progressing on pembrolizumab or a pembrolizumab-based regimen.\n6. ECOG performance status of 0 or 1 at screening.\n7. Has adequate bone marrow function, defined as:\n\n   1. Platelet count ≥ 75,000\u002Fmm3.\n   2. Hemoglobin ≥ 9.0 g\u002FdL (\n   3. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n8. Has adequate organ function, defined as: a) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×upper limit of normal (ULN); (≤ 5.0 × ULN if transferase elevation is due to liver metastases) AND b) Total bilirubin ≤ 1.5 × ULN (\\\u003C 3.0 × ULN in the presence of documented Gilbert's syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases at baseline). c) Creatinine clearance ≥ 30 mL\u002Fmin as calculated using the Cockcroft-Gault equation). d) International normalized ratio (INR) \\\u003C 1.5 without anticoagulants, INR \\\u003C 3 if on prophylactic anticoagulation therapy.\n\n   e) Prothrombin time (PT) and either partial thromboplastin (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n9. Completion of prior therapy with required washout and recovery:\n\n   * Cytotoxic chemotherapy: \\> 14 days from the last dose.\n   * Monoclonal antibodies (e.g., bevacizumab, ramucirumab): ≥ 5 half-lives or ≥ 42 days, whichever is longer.\n   * Recovered to ≤ Grade 1 from prior therapy-related clinical toxicities (except alopecia and stable endocrine replacement).\n10. Projected life expectancy ≥ 12 weeks (or 3 months) in the opinion of the Investigator.\n11. Pregnancy test (for females of childbearing potential) negative at screening.\n12. Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n\nExclusion Criteria:\n\nParticipants meeting any exclusion criteria for this trial will be disqualified from entering the study.\n\n1. Has a known actionable genomic alteration, including EGFR, ALK, or ROS1 rearrangements, for which approved targeted therapy exists. Participants who are receiving or have previously received tyrosine kinase inhibitor (TKI) therapy targeting EGFR, ALK, or ROS1 are excluded.\n2. Prior therapy with docetaxel either as monotherapy or in combination with other agents.\n3. Prior treatment with CTLA-4 inhibitor (e.g., ipilimumab).\n4. History of severe irAEs related to ICI.\n5. Has a known history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years is excluded. Note: Participants receiving physiologic corticosteroid replacement (e.g., ≤ 10 mg\u002Fday prednisone equivalent) are eligible.\n6. History of hypersensitivity or allergic reactions to valacyclovir.\n7. Active, uncontrolled, clinically significant bacterial, fungal, or viral infection, or any ongoing infection requiring systemic therapy.\n8. Clinically active central nervous system (CNS) metastases or leptomeningeal disease. Evidence of new or progression of CNS confirmed by imaging during the study screening.\n9. Persistently symptomatic bone metastases.\n10. Has liver metastases involving more than half of the liver.\n11. Prior radiotherapy within 2 weeks of the start of the study drug.\n12. Has a known history of active interstitial lung diseases (ILD) (≥ grade 2) or noninfectious pneumonitis requiring active therapy, or for whom suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening, or clinically severe pulmonary compromise due to intercurrent pulmonary illness and\u002For pulmonary disorder (e.g., severe chronic obstructive pulmonary disease, restrictive lung disease, etc.) requiring supplemental oxygen (\\>2L\u002Fmin at rest) or any autoimmune, connective tissue or inflammatory disorders with active pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or any prior pneumonectomy.\n13. Receiving or anticipated to receive investigational agents or has used an investigational device within 4 weeks prior to the first dose of study drug.\n14. Ongoing clinically significant toxicity (\\> Grade 2 except alopecia), associated with prior treatment including systemic therapy, radiotherapy, or surgery.\n15. Has a known history of Human Immunodeficiency Virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS)-related illness.\n16. Has a known active or known prior history of Hepatitis B (HBV) infection (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive or detectable quantitative levels of HBV DNA) or known active Hepatitis C (HCV) (e.g., hepatitis C virus RNA \\[quantitative\\] is detected).\n17. Has an uncontrolled or significant heart disease, defined as:\n\n    1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \\> 470 msec (based on the average of Screening triplicate 12-lead electrocardiogram \\[ECG\\] determinations).\n    2. Myocardial infarction or uncontrolled\u002Funstable angina within 6 months before randomization.\n    3. Congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV) at Screening (see Appendix 12.3).\n    4. Uncontrolled or significant cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication).\n    5. NYHA Class III or IV Functional Classification.\n    6. LVEF \\\u003C 40% by ECHO or MUGA scan within 28 days before randomization.\n    7. Uncontrolled hypertension (resting systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg) within 28 days before randomization.\n18. Has a concurrent malignancy requiring active systemic or local anti-cancer treatment except for the following:\n\n    * Adequately treated non-melanoma skin cancer (squamous or basal cell cancers).\n    * In situ cervical cancer that has been adequately treated.\n    * Early-stage malignancies under active surveillance or observation only, including but not limited to:\n\n      * Low-risk prostate cancer managed with active surveillance- Ductal carcinoma in situ of the breast managed with observation\n19. Participants of childbearing potential, who are pregnant, lactating, or intend to become pregnant or father children during the study.\n20. Any other significant physical and medical co-morbid conditions, including psychiatric conditions that, in the opinion of the Investigator, would impair study participation or cooperation.",{"count":84,"type":20},500,[23],"This phase III trial compares the effect of the combination of aglatimagene besadenovec and pembrolizumab versus standard of care docetaxel chemotherapy for the treatment of stage IV non-squamous, non-small cell lung cancer. Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral prodrug (valacyclovir), injection of aglatimagene induces targeted tumor cell death and stimulates a systemic immune response. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving aglatimagene with pembrolizumab is more effective at treating patients with stage IV non-squamous, non-small cell lung cancer than standard chemotherapy.",[88],"Non-squamous, Non-Small Cell Lung Cancer",[90,91,92,93,35,94,95],"NSCLC","Non-Squamous","CAN-2409","Aglatimagene besadenovec","Docetaxel","Non-Small Cell Lung Cancer","2026-06-17",{"date":98,"type":43},"2026-06-22",{"date":100,"type":20},"2026-06-15",{"date":102,"type":20},"2031-10-22",{"name":104,"class":50},"Candel Therapeutics, Inc.",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100593335","phase-2-a-study-to-assess-adverse-events-change-in-disease-activity-of-intravenous-telisotuzumab-adizutecan-in-combination-with-osimertinib-as-first-line-treatment-in-adult-participants-with-locally-advanced-unresectable-or-metastatic-egfr-mutated-non-squamous-non-small-cell-lung-cancer-100593335","NCT07005102","A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","A Phase 2\u002F3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.\n* Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.\n* Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.\n* Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \\[any grade\\] or Grade \\\u003C= 2 peripheral neuropathy).\n* Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.\n* No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and\u002For metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that \\>= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.\n* Diagnosis of histologically or cytologically confirmed metastatic\u002Flocally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records.\n\nExclusion Criteria:\n\n* History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.\n* History of any malignancy other than disease under study except for\n\n  1. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator.\n  2. Successfully treated nonmelanoma skin cancer.\n  3. Localized carcinoma in situ of the cervix.\n  4. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.",{"count":114,"type":20},854,[116,23],"PHASE2","Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity \"when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum\u002Fpemetrexed chemotherapy).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide.\n\nIn Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[119],"Non-Squamous Non-Small Cell Lung Cancer",[119,121,122,37,36,38,123,124,125,126,127],"Telisotuzumab Adizutecan","Osimertinib","ABBV-400","Stand of Care","Cancer","Chemotherapy","Platinum Chemotherapy","2026-06-04",{"date":130,"type":43},"2026-06-08",{"date":132,"type":43},"2025-08-03",{"date":134,"type":20},"2036-11",{"name":136,"class":50},"AbbVie",53,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":149,"conditions":150,"keywords":160,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":105},"100638760","phase-1-a-study-of-idp-001-in-advanced-or-metastatic-solid-tumors-100638760","NCT07602842","A Study of IDP-001 in Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Measurable disease per RECIST v1.1\n* Participant willing to provide tumor biopsies\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n* Life expectancy greater than 12 weeks\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Any clinically significant corneal disorder\n* Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Active significant neurologic disorders\n* Requires home oxygen\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* History of major immunologic reaction to prior immunoglobulin G-containing agent\n* Clinically significant ascites or liver disease\n* Uncontrolled diabetes or diabetic neuropathy\n* Active bleeding disorders\n* Participation in a concurrent clinical study in the treatment period\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to IDP-001 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Has had a seizure prior to Screening\n* Prior solid organ transplant or allogeneic stem cell transplant\n* Current endocrinopathy\n* History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis\n* History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids\n* Stroke or transient ischemic attack prior to Screening\n* Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":146,"type":20},132,[148,116],"PHASE1","This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).",[151,152,153,154,155,156,157,158,159],"Advanced Solid Tumor","Metastatic Solid Tumor","Head and Neck Squamous Cell Carcinoma","Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of the Cervix","Non Squamous Non Small Cell Lung Cancer","Squamous Cell Carcinoma of the Esophagus","Squamous Cell Carcinoma of the Anus","Squamous Cell Carcinoma",[90,161],"Squamous NSCLC","NOT_YET_RECRUITING","2026-05-19",{"date":165,"type":43},"2026-05-22",{"date":167,"type":20},"2026-06",{"date":169,"type":20},"2028-12",{"name":171,"class":50},"InduPro, Inc.",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":105},"100582863","phase-2-phase-ii-clinical-study-of-js207-pd-1vegf-bispecific-antibody-combination-therapies-in-patients-with-driver-gene-positive-advanced-non-small-cell-lung-cancer-after-failure-of-tki-therapy-100582863","NCT06868836","Phase II Clinical Study of JS207 (PD-1\u002FVEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.\n2. Locally advanced (stage IIIB\u002FIIIC), metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.\n3. Positive for driver genes, including but not limited to any of the following: EGFR sensitive mutations (18 exon G719X mutation, 19 exon deletion mutation, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 exon insertion mutation.\n4. Previous targeted therapy failed and there is currently no standard targeted treatment available.\n5. Cohort1: PD-L1 positive (TPS ≥ 1%) confirmed by the central laboratory or the research center. Cohort2:: Organized samples must be provided for the central laboratory to conduct retrospective biomarker testing (which may include PD-L1, EGFR and HER3 expression).\n6. Being able to provide a qualified test report for positive driver gene, or agreeing to provide a qualified sample for driver gene testing.\n7. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.\n8. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n9. Expected survival period ≥ 12 weeks.\n10. The function of important organs meets the requirements of the protocol.\n11. For female subjects with reproductive capacity who have sexual relations with unsterilized male partners, they must agree to have no pregnancy plans and to take effective contraceptive measures during the period from signing the ICF to 7 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement). For unsterilized male subjects who maintain sexual relations with female partners with reproductive capacity, they must agree to take effective contraceptive measures during the period from signing the ICF to 4 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement) (Appendix 4). For female patients with reproductive capacity, the HCG test in the 7 days prior to study enrollment must be negative and they must be non-lactating.\n12. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.\n\nExclusion Criteria:\n\n1. Diseases accompanied by those listed in the protocol, including those with histopathological or cytopathological confirmation of the tumor combined with neuroendocrine tumor (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) components, or with the squamous cell carcinoma component exceeding 10%; known meningeal metastasis; symptomatic brain metastasis; the tumor encircling important blood vessels or with obvious necrosis and cavities, and the investigator deems that it may pose a risk of bleeding, etc.\n2. Received the treatments listed in the plan, including immune-mediated treatments; systemic chemotherapy, anti-VEGF pathway target drugs, anti-EGFR and\u002For HER3 target drugs, and ADC drugs containing topoisomerase inhibitors (only applicable to cohort 2).\n3. Having an obvious bleeding tendency or a history of severe coagulation dysfunction.\n4. Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation\u002Ffistula formation of the hollow viscus as judged by the investigator.\n5. Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.\n6. Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.\n7. Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).\n8. Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin\u002Fcisplatin), or known history of ≥ grade 3 allergy to antibody drugs in the past.\n9. Having an active autoimmune disease or a history of autoimmune disease.\n10. Having a history of immunodeficiency.\n11. Having a severe infection within 4 weeks before the first use of the investigational drug.\n12. History of confirmed or suspected interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonia, idiopathic pneumonia, or other moderate to severe lung diseases that seriously affect lung function.\n13. Active pulmonary tuberculosis infection detected by medical history or CT examination.\n14. Having active tuberculosis, hepatitis B, or hepatitis C.\n15. Having been diagnosed with any other malignant tumor within 5 years before the first use of the investigational drug.\n16. Uncontrolled concurrent diseases listed in the protocol.\n17. As judged by the investigator, having other severe, acute or chronic medical diseases, mental diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results. \"","75 Years",{"count":180,"type":20},78,[116],"This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg\u002Fkg, IV, d1) + pemetrexed (500 mg\u002Fm², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg\u002Fm², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 ：The treatment received was JS207 (10mg\u002Fkg, intravenous, on day 1) + JS212 (4.2mg\u002Fkg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.",[26],"2026-05-13",{"date":186,"type":43},"2026-05-18",{"date":188,"type":43},"2025-03-30",{"date":190,"type":20},"2028-04-04",{"name":192,"class":193},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100568910","phase-3-a-study-to-compare-pharmacokinetics-efficacy-safety-and-immunogenicity-of-mb12-proposed-pembrolizumab-biosimilar-to-keytruda-in-non-small-cell-lung-cancer-benito-study-100568910","NCT06687369","A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)","Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)","Inclusion Criteria:\n\n1. Adult male\u002Ffemale patients ≥18 years old at the time of signing the informed consent form (ICF).\n2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \\[TNM\\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.\n4. Known status of PD-L1 expression.\n5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.\n\nExclusion Criteria:\n\n1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.\n2. Known history of central nervous system metastases and\u002For carcinomatous meningitis.\n3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).\n4. Major surgery within 3 weeks of the first dose of study treatment.\n5. Active autoimmune disease that has required systemic treatment in the last 2 years.\n6. Contraindication and\u002For intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.\n7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.",{"count":202,"type":20},726,[23],"This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.",[156],"2026-03-10",{"date":208,"type":43},"2026-03-11",{"date":210,"type":43},"2024-12-30",{"date":212,"type":20},"2027-09",{"name":214,"class":50},"mAbxience Research S.L.",151,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":105},"100613302","phase-2-a-study-of-bl-m07d1-in-combination-with-pembrolizumab-in-patients-with-unresectable-locally-advanced-or-metastatic-her2-overexpressing-non-squamous-nsclc-100613302","NCT07264816","A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age at the time of signing the informed consent form ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;\n6. Confirmed known HER2 overexpression;\n7. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;\n8. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;\n9. ECOG performance status score of 0 or 1;\n10. Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n12. Organ function levels must meet the requirements;\n13. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should take adequate and highly effective contraception throughout the treatment cycle and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;\n2. Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;\n3. Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;\n4. History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;\n5. Concurrent pulmonary disease leading to severe impairment of lung function;\n6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n7. Diagnosed with other primary malignancies within 5 years before the first dose;\n8. Poorly controlled hypertension;\n9. History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD\u002Finterstitial pneumonia, etc.;\n10. Patients with central nervous system metastases, carcinomatous meningitis, and\u002For spinal cord compression;\n11. Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-M07D1, pembrolizumab, or any excipient components;\n12. Required systemic corticosteroid or immunosuppressive therapy within 2 weeks before the study administration;\n13. Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;\n14. New deep vein thrombosis within 14 days, excluding patients with venous filters implanted;\n15. Systemic severe infection within 4 weeks before screening;\n16. Active autoimmune diseases and inflammatory diseases;\n17. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, or hepatitis C virus infection;\n18. History of allogeneic stem cell, bone marrow, or organ transplantation;\n19. Presence of severe neurological or psychiatric disorders;\n20. Presence of other severe physical or laboratory abnormalities, poor compliance, etc., which may increase the risk of participation in the study, interfere with study results, or patients deemed unsuitable for participation in the study by the investigator.",{"count":224,"type":20},80,[116],"This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.",[26],"2026-03-04",{"date":230,"type":43},"2026-03-05",{"date":232,"type":43},"2026-02-03",{"date":234,"type":20},"2027-12",{"name":236,"class":50},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":105},"100622399","phase-3-phase-iii-clinical-study-of-hb0025-combined-with-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-as-first-line-treatment-for-advanced-nonsquamous-non-small-cell-lung-cancer-100622399","NCT07383116","Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer","A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Injection Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Able to fully understand and voluntarily sign the informed consent form, and willing and able to comply with the clinical study procedures and follow-up visits.\n2. Aged 18 to 75 years old (inclusive of both upper and lower limits), male and female subjects are eligible.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n4. Expected survival ≥ 12 weeks.\n5. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint Committee on Cancer \\[AJCC\\]), which is inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy as well as immunotherapy as consolidation treatment.\n\n   Note: For subjects with locally advanced (Stage IIIB\u002FIIIC) non-squamous NSCLC who are inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy as well as immunotherapy as consolidation treatment, assessment by relevant specialist physicians and provision of written documentation are required for confirmation.\n6. No prior systemic antineoplastic treatment for the study disease (including systemic chemotherapy, targeted therapy, and immunotherapy).\n\n   Note: Subjects who previously received neoadjuvant, adjuvant, or radical concurrent\u002Fsequential chemoradiotherapy for non-metastatic disease with curative intent are eligible if disease progression occurs \\> 180 days after the last dose of prior treatment.\n7. Subjects must provide tumor tissue samples (archived or freshly obtained) collected at or after the diagnosis of locally advanced or metastatic tumor for central laboratory testing of PD-L1 expression.\n\n   Note: The following samples are not accepted: fine-needle aspiration samples (without intact tissue structure, only cell suspensions or smears), brush cytology samples, cell smears from centrifuged pleural effusion drainage, bronchoalveolar lavage fluid samples, and bone lesions without soft tissue components or decalcified bone tumor samples. Tumor lesions used for fresh tissue biopsy should not be designated as RECIST v1.1 target lesions, unless the lesion is the only measurable lesion. For archived samples, they must be collected after the last systemic treatment, and the collection site must not have received radiotherapy. If a subject's archived samples do not meet the above requirements and the investigator judges that a biopsy is not in the subject's best interest, the use of archived samples may be permitted after discussion with the sponsor.\n8. No sensitive EGFR mutations or ALK gene rearrangements. Prior tissue-based test reports for EGFR and ALK status must be provided. If the test reports do not meet the study requirements or are unavailable, tumor tissue samples must be provided for assessment of EGFR and ALK status (tested by a local laboratory recognized by the study site or the central laboratory) before enrollment.\n\n   Note: For subjects with squamous NSCLC (excluding mixed-type NSCLC, e.g., adenosquamous carcinoma) who have a smoking history or are current smokers, if the prior EGFR and ALK status is unknown, testing for these markers is not required before enrollment, and they will be deemed negative.\n9. Per RECIST v1.1 criteria (see Appendix 2), the subject must have at least one measurable (non-brain metastatic) lesion suitable for repeated and accurate measurement. Tumor lesions previously treated with radiotherapy or other local therapies must not be designated as target lesions, unless:\n\n   The lesion is the only measurable lesion, and the investigator can provide imaging evidence (both pre- and post-local treatment) confirming clear disease progression of the lesion following local therapy; The lesion used for fresh tissue biopsy must not be designated as a target lesion, unless it is the only measurable lesion and the biopsy date is more than 4 weeks prior to the first dose of study treatment.\n10. Confirmed adequate organ function, with mandatory compliance with the following laboratory parameters:\n\nHematology (no receipt of any blood component transfusion or hematopoietic growth factor support therapy within 14 days prior to screening tests):\n\n1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n2. Platelet Count (PLT) ≥ 100 × 10⁹\u002FL;\n3. Hemoglobin (HGB) ≥ 90 g\u002FL;\n\nRenal function:\n\n1. Serum Creatinine (Scr) ≤ 1.5 × Upper Limit of Normal (ULN), and Creatinine Clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3 for details);\n2. Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein excretion must be \\\u003C 1 g;\n\nHepatic function:\n\n1. Serum Total Bilirubin (TBiL) ≤ 1.5 × ULN; for subjects with liver metastasis or confirmed Gilbert's syndrome, TBiL ≤ 3 × ULN;\n2. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastasis, ALT and AST ≤ 5 × ULN;\n3. Serum Albumin (ALB) ≥ 30 g\u002FL; Coagulation function: Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator must confirm that both INR and APTT are within the safe and effective therapeutic range); Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 11. Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the screening period until 90 days after the last dose of study treatment. Discussion with the investigator is required to determine whether contraception can be discontinued after this period. Female subjects must not be breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days before randomization.\n\nExclusion Criteria:\n\n1. Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components \\[mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment\\].\n2. Known presence of driver gene alterations with approved first-line therapeutic options, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.\n3. History of a second primary malignancy within 5 years before screening (enrollment is permitted for other malignancies cured by local treatment, e.g., carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, \\\u003C T1 urothelial carcinoma, and papillary microcarcinoma of the thyroid).\n4. Symptomatic central nervous system (CNS) metastasis. For subjects with asymptomatic CNS metastasis or those with symptomatically stable CNS metastasis for ≥ 4 weeks prior to randomization, enrollment is permitted only if all the following criteria are met:\n\n   * No metastasis to the meninges, midbrain, pons, medulla oblongata, spinal cord, or spinal cord compression; ② No increase in lesion size or new lesions after treatment;\n\n     * No history of intracranial hemorrhage;\n\n       * Discontinuation of corticosteroid therapy for ≥ 2 weeks prior to randomization; ⑤ No significant perilesional edema surrounding brain metastases; ⑥ The longest diameter of brain metastases ≤ 1.5 cm.\n5. Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1\u002FL2, anti-CTLA-4 agents), immune checkpoint agonists (e.g., ICOS, CD40, GITR, OX40, CD137 agents), or cellular immunotherapy, or any treatment targeting the tumor immune mechanism. Additionally, for subjects who previously received PD-(L)1 inhibitors in the neoadjuvant\u002Fadjuvant setting or as consolidation therapy after definitive chemoradiotherapy, enrollment may be permitted (with sponsor approval) if the interval between the end of the last treatment and the occurrence of disease progression is more than 12 months.\n\n   Note: For subjects with prior PD-(L)1 inhibitor exposure:\n\n   Enrollment is prohibited if the subject experienced ≥ Grade 3 immune-related adverse events (irAEs) caused by prior immunotherapy (excluding endocrine-related irAEs), irAEs leading to permanent treatment discontinuation, ≥ Grade 2 immune-related cardiotoxicity, or immune-related neurological or ophthalmic irAEs of any grade; Screening is prohibited if all adverse events caused by prior immunotherapy have not been fully resolved or resolved to Grade 1 before study screening. For subjects with ≥ Grade 2 endocrine-related irAEs, enrollment is permitted if the condition is stable and asymptomatic with appropriate replacement therapy.\n6. Prior receipt of systemic anti-angiogenic therapy, including but not limited to bevacizumab and its biosimilars, Endostar, small-molecule TKIs, and ramucirumab.\n7. Prior anti-tumor therapy or concomitant medication (the washout period is calculated from the end date of the last treatment):a) Participation in any clinical trial within 28 days prior to the first dose;b) Receipt of anti-tumor therapy within 4 weeks prior to the first dose or within 5 half-lives of the drug (whichever is longer), including but not limited to chemotherapy, radiotherapy (thoracic radiotherapy with a dose \\> 30 Gy within 180 days prior to the first dose; non-thoracic radiotherapy with a dose \\> 30 Gy within 4 weeks prior to the first dose; local palliative radiotherapy with a dose ≤ 30 Gy for non-target lesions within 2 weeks prior to the first dose), targeted therapy, immunotherapy, or endocrine therapy;c) Use of Chinese herbal medicines (including patent Chinese medicines) with anti-tumor indications within 2 weeks prior to the first dose; use of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first dose;d) Need for systemic administration of corticosteroids at a dose \\> 10 mg\u002Fday of prednisone or equivalent dose, or other immunomodulators within 2 weeks prior to randomization. \\[Short-term administration (≤ 7 days) for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by allergen exposure), or local administration (e.g., intraocular, intra-articular, intranasal, or inhaled administration) is permitted for enrollment\\];e) Use or current use of anticoagulants such as warfarin, heparin (excluding heparin for catheter locking or deep vein catheterization), dabigatran etexilate, rivaroxaban, etc., or antiplatelet drugs such as aspirin, clopidogrel, dipyridamole, cilostazol, or other known antiplatelet agents within 2 weeks prior to the first dose.\n8. Major surgery or severe trauma within 4 weeks before the first dose of study treatment; inadequate recovery from prior surgery (as judged by the investigator); anticipated need for major surgery during the study; minor local surgery (e.g., needle biopsy, endoscopy, interventional procedure\u002Fexamination, excluding vascular access establishment) within 7 days before randomization; presence of incompletely healed surgical incisions or wounds.\n9. Active autoimmune disease requiring systemic treatment (e.g., treatment with immunomodulators or corticosteroids) within 2 years before screening, except for replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n10. Presence of any of the following infections:\n\n    1. Severe infection (including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia) within 4 weeks before the first dose of study treatment; active infection requiring systemic anti-infective treatment (with antibiotics for ≥ 7 days) within 2 weeks before the first dose of study treatment;\n    2. Known active tuberculosis (TB) (subjects with suspected active TB must undergo clinical examination to rule out the diagnosis);\n    3. Known active syphilis infection;\n    4. Has a known history of HIV;\n    5. Active hepatitis B or hepatitis C; asymptomatic hepatitis B virus (HBV) carriers (HBV DNA ≤ 200 IU\u002Fml or ≤ 1000 copies\u002Fml or below the lower limit of detection, whichever is applicable) or subjects with clinically cured hepatitis C (HCV RNA below the lower limit of detection) are permitted for enrollment.\n\n    Note: Anti-HBV treatment is required for HBsAg-positive subjects during the study treatment period.\n11. Known hypersensitivity to protein drugs, recombinant proteins, components of HB0025, and\u002For components of chemotherapy drugs (pemetrexed and carboplatin\u002Fcisplatin).\n12. Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n13. Presence of any of the following severe comorbidities:\n\n    1. Clinically significant bleeding (including but not limited to hemoptysis \\[defined as coughing up or expectorating ≥ 1 teaspoon (approximately 5 ml) of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum or transient hemoptysis related to diagnostic bronchoscopy or lung biopsy are permitted\\], gastrointestinal bleeding, nasal bleeding \\[subjects with bloody nasal discharge are permitted\\]) within 4 weeks before the first dose of study treatment; any arterial thrombosis or embolism event, or significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 180 days before the first dose of study treatment; history of deep vein thrombosis within 90 days before the first dose of study treatment;\n    2. Imaging findings at screening showing: Tumor invasion of large blood vessels (e.g., central pulmonary artery, central pulmonary vein, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava); tumor invasion of vital organs (e.g., heart, trachea, esophagus, main bronchus); or imaging evidence of risk for esophagotracheal fistula or esophagopleural fistula; tumor encasement of large blood vessels with vascular stenosis; or pulmonary lesions with obvious necrosis\u002Fcavitation (as judged by the investigator to pose a bleeding risk if enrolled);\n    3. History of persistent bleeding disorders or coagulation disorders (past or current);\n    4. Clinically significant (e.g., active) cardiovascular or cerebrovascular disease within 180 days prior to the first dose, including but not limited to unstable angina requiring hospitalization, myocardial infarction, myocarditis, cardiomyopathy, congestive heart failure of New York Heart Association (NYHA) Class ≥ III, poorly controlled severe arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or vascular disease (e.g., aortic aneurysm at risk of rupture); or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia). Prolonged Fridericia-corrected QT interval (QTcF) on electrocardiogram: \\> 450 ms for males and \\> 470 ms for females.\n    5. History of conditions potentially causing gastrointestinal bleeding or perforation (e.g., gastrointestinal obstruction, acute Crohn's disease, ulcerative colitis, esophagogastric varices, gastrointestinal perforation, unhealed wound, intra-abdominal abscess, or acute gastrointestinal bleeding) within 180 days before the first dose of study treatment; subjects with chronic Crohn's disease or ulcerative colitis (excluding those who have undergone total colectomy and proctectomy) are excluded, even if in remission;\n    6. History of gastrointestinal fistula or genitourinary fistula (past or current) that remains unhealed after surgical treatment;\n    7. Hydronephrosis unrelieved by nephrostomy or ureteral stenting, or infected hydronephrosis\u002Fhydroureter;\n    8. Current presence of third-space fluid collections (e.g., pleural effusion, pericardial effusion, abdominal\u002Fpelvic effusion) requiring repeated puncture\u002Fdrainage for local management; or receipt of local drainage within 2 weeks before the first dose of study treatment;\n    9. Acute exacerbation of chronic obstructive pulmonary disease within 30 days before the first dose of study treatment;\n    10. Current presence of uncontrolled comorbidities, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis (enrollment decision requires joint discussion between the investigator and the sponsor).\n14. Current presence of interstitial lung disease, pneumoconiosis, or drug\u002Fradiotherapy-related pneumonia requiring treatment.\n15. Unresolved adverse events from prior treatment (defined as adverse events not resolved to Grade 0 or 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] Version 5.0, or to the level specified in the inclusion\u002Fexclusion criteria), except for alopecia. Subjects with irreversible toxicity (e.g., hearing loss) that is not expected to worsen after administration of study drugs may be enrolled after consultation with the medical monitor. Subjects with long-term radiotherapy-induced toxicity (judged by the investigator as irreversible) may be enrolled after consultation with the medical monitor.\n16. Pregnancy, lactation, or plans to breastfeed during the study.\n17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n18. Receipt of live virus vaccines or attenuated live vaccines within 30 days before randomization, or planned vaccination during the study (Note: Inactivated vaccines are permitted).\n19. Known history of mental illness, alcoholism, drug addiction, or substance abuse.\n20. Past or current presence of uncontrolled metabolic disorders, non-tumor-related local\u002Fsystemic diseases, tumor-induced diseases or symptoms (e.g., cachectic manifestations: weight loss \\> 10% within 3 months before screening), laboratory abnormalities, or any treatment that may pose a high medical risk, confound study results, interfere with the subject's full participation in the study, or make study participation not in the subject's best interest.\n21. Subjects deemed unsuitable for study participation by the investigator for other reasons.",{"count":84,"type":20},[23],"This study is a randomized, controlled, double-blind, multicenter Phase III registration clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (pemetrexed plus carboplatin\u002Fcisplatin) versus tislelizumab combined with chemotherapy (pemetrexed plus carboplatin\u002Fcisplatin) as a first-line treatment for unresectable locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) nonsquamous non-small cell lung cancer (NSCLC).\n\nThe study will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 500 subjects. After being eligible for screening, patients will be randomly assigned to the study groups at a ratio of 1:1 to receive either HB0025 combined with chemotherapy (experimental group) or tislelizumab combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 4 cycles of treatment, patients will enter the maintenance therapy phase with HB0025 or tislelizumab plus pemetrexed (Q3W). The treatment will last until the investigator determines that there is no longer clinical benefit (based on comprehensive assessment of RECIST v1.1 imaging results and clinical symptoms), intolerable toxicity occurs, 35 cycles of study treatment are completed, or other treatment termination criteria specified in the protocol are met, whichever comes first.",[248],"Non Squamous Non-small Cell Lung Cancer",[250,251,252],"HB0025","Fist Line treatment","nonsq NSCLC","2026-02-01",{"date":232,"type":43},{"date":256,"type":20},"2026-01-15",{"date":258,"type":20},"2028-04-10",{"name":260,"class":50},"Shanghai Huaota Biopharmaceutical Co., Ltd.",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":279,"locationsCount":105},"100606687","phase-3-a-study-of-bl-m07d1-vs-pembrolizumab-platinum-chemotherapy-in-first-line-treatment-of-her2-mutant-advanced-or-metastatic-non-squamous-nsclc-100606687","NCT07178795","A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC","A Randomized Controlled Phase III Clinical Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;\n3. Expected survival time ≥12 weeks;\n4. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;\n5. HER2 functional mutation confirmed by a central laboratory;\n6. Provide the most recent tumor tissue meeting the requirements for biomarker testing by the central laboratory;\n7. Must have at least one measurable target lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from previous anti-tumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. Organ function levels must meet the requirements;\n11. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days prior to the start of treatment, and the serum pregnancy test must be negative. They must not be breastfeeding. All enrolled patients (regardless of gender) should take adequate and highly effective contraceptive measures throughout the treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;\n2. Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;\n3. Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;\n4. Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;\n5. History of severe cardiovascular or cerebrovascular diseases within the past 6 months prior to screening;\n6. Concurrent pulmonary diseases leading to severe impairment of lung function;\n7. History of ILD\u002Finterstitial pneumonia requiring steroid treatment or current diagnosis of ILD\u002Finterstitial pneumonia;\n8. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n9. Diagnosis of other primary malignancies within 5 years prior to the first dose;\n10. Newly developed deep vein thrombosis within 14 days prior to screening;\n11. Hypertension poorly controlled by antihypertensive medications;\n12. Patients with central nervous system (CNS) metastases, carcinomatous meningitis (leptomeningeal metastases), and\u002For spinal cord compression;\n13. Patients with a history of severe allergies to any excipients or components of the investigational drug;\n14. History of autologous or allogeneic stem cell transplantation or organ transplantation;\n15. Positive human immunodeficiency virus antibody, active hepatitis B virus infection, liver cirrhosis, or hepatitis C virus infection;\n16. Occurrence of severe infections within 4 weeks prior to the first use of the investigational drug;\n17. Patients with significant serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;\n18. Systemic corticosteroid treatment with \\>10 mg\u002Fd prednisone or equivalent prior to randomization;\n19. Presence of severe neurological or psychiatric disorders;\n20. Subjects with clinically significant bleeding or obvious bleeding tendencies within 4 weeks prior to signing informed consent;\n21. Conditions such as intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea;\n22. Subjects planning to receive or having received live vaccines within 28 days prior to the first dose;\n23. Presence of other severe physical or laboratory abnormalities, poor compliance, or any other factors that may increase the risk of participation in the study, interfere with study results, or make the patient unsuitable for participation in the study as determined by the investigator.",{"count":269,"type":20},440,[23],"This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.",[26],"2025-11-13",{"date":275,"type":43},"2025-11-17",{"date":277,"type":43},"2025-09-29",{"date":234,"type":20},{"name":236,"class":50},{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100548131","phase-2-a-study-of-hs-20117-combined-with-aumolertinib-in-participants-with-advanced-non-squamous-non-small-cell-lung-cancer-100548131","NCT06417008","A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","A Phase Ib\u002FIII Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Males or females aged 18 - 75 years (inclusive).\n* Participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB\u002FIIIC\u002FIV) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.\n* Agree to provide fresh or archival tumor tissue.\n* At least one target lesion per the RECIST v1.1.\n* ECOG performance status of 0-1.\n* Minimum life expectancy \\> 12 weeks.\n* Males or Females should be using adequate contraceptive measures throughout the study.\n* Females must not be pregnant at screening or have evidence of non-childbearing potential.\n* Have signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Received or are receiving the following treatments:\n\n  1. Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC).\n  2. Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug.\n  3. Presence of pleural effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion.\n  4. Other investigational non-anti-tumor drugs, strong CYP3A4 inhibitors, strong inducers, drugs that are sensitive substrates of BCRP or P-gp, or drugs that prolong the QT interval within the washout period.\n* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n* History of other primary malignancies.\n* Untreated, or active central nervous system metastases.\n* Inadequate bone marrow reserve or organ functions.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Severe or uncontrolled systemic diseases.\n* Severe bleeding symptoms or bleeding tendencies.\n* Severe arteriovenous thrombosis occurred.\n* Serious or active infection.\n* Active infectious diseases.\n* Interstitial lung disease (ILD).\n* Serious neurological or mental disorders.\n* History of hypersensitivity to any component of HS-20117 and Aumolertinib or their similar drugs.\n* Female subjects who are pregnant, lactating, or planning to become pregnant or breastfeed during the study period or within 6 months after the last dose of the study drug.\n* Subjects with a history of severe allergic reactions or those who have experienced severe infusion reactions\n* Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.",{"count":288,"type":20},1080,[116,23],"HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \\[Exon 19del\\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).",[119],[95,293,294,295,296],"HS-20117","Epidermal Growth Factor Receptor","c-Mesenchymal-Epithelial Transition","Bispecific Antibody","2025-07-30",{"date":299,"type":43},"2025-08-01",{"date":301,"type":43},"2024-05-28",{"date":303,"type":20},"2030-06-01",{"name":305,"class":50},"Hansoh BioMedical R&D Company",2,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":105},"100588299","phase-3-a-study-to-compare-effects-and-safety-of-ct-p51-and-keytruda-in-patients-with-previously-untreated-metastatic-lung-cancer-100588299","NCT06939595","A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer","A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Stage IV, non squamous NSCLC\n* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC\n* Have at least 1 measurable lesion per RECIST version 1.1\n\nExclusion Criteria:\n\n* Have predominantly squamous cell histology NSCLC.\n* Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin",{"count":315,"type":20},606,[23],"The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.",[156],"2025-04-21",{"date":321,"type":43},"2025-04-23",{"date":323,"type":43},"2025-01-30",{"date":325,"type":20},"2028-07",{"name":327,"class":50},"Celltrion",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":335,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100581209","phase-3-a-study-to-compare-the-efficacy-safety-immunogenicity-and-pharmacokinetic-profile-of-hlx17-vs-keytruda-in-the-first-line-treatment-of-advanced-non-squamous-non-small-cell-lung-cancer-100581209","NCT06847334","A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I\u002FIII Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.\n* Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.\n* Have not received prior systemic treatment for their advanced\u002Fmetastatic NSCLC.\n* At least one measurable lesion as assessed by IRRC based on RECIST v1.1.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Have adequate organ function.\n\nExclusion Criteria:\n\n* Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.\n* Subjects with other active malignancies within 5 years or at the same time prior to screening.\n* Active central nervous system metastases.\n* Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.\n* Known active or suspected autoimmune diseases.\n* History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.\n* Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.\n* Pregnant or breastfeeding female.\n* The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.",{"count":336,"type":20},772,[23],"This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I\u002FIII clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.",[119],[341],"Keytruda biosimilar","2025-02-21",{"date":344,"type":43},"2025-02-26",{"date":346,"type":20},"2025-04-27",{"date":348,"type":20},"2028-01-24",{"name":350,"class":50},"Shanghai Henlius Biotech",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":21,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":105},"100571746","phase-2-a-multicenter-open-label-phase-iia-clinical-study-to-evaluate-the-efficacy-and-safety-of-b1962-injection-in-the-treatment-of-advanced-malignant-solid-tumors-100571746","NCT06724263","A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for enrollment in this study:\n\n  1. Voluntary participation in the study and provision of signed and dated informed consent;\n  2. Age ≥ 18 years at the time of informed consent;\n  3. Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed or failed to respond to first-line standard therapy, or cannot tolerate standard therapy, or have no standard effective treatment regimen, or refuse standard therapy; and no more than 4 lines of prior systemic anti-tumor therapy. Specific tumor species cohorts were as follows:\n\n     * Recurrent platinum-resistant epithelial ovarian cancer (including primary peritoneal and\u002For fallopian tube cancer): pathologically confirmed ovarian epithelial malignancy, fallopian tube epithelial malignancy, primary peritoneal cancer; and diagnosed platinum-resistant (duration of response to platinum-based therapy is within 6 months after the last dose of platinum-based therapy)\n\n       * Triple-negative breast cancer: pathologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2. ER, PR negativity was defined as: IHC ER \\\u003C 1%, IHC PR \\\u003C 1%. HER-2 negativity is defined as IHC HER-2 (-) or (1 +), and FISH must be performed and the result is negative for HER-2 (2 +) ③ Cervical cancer: pathologically confirmed inoperable locally advanced or metastatic cervical cancer\n\n         * Small-cell lung cancer: histologically or cytologically confirmed, inoperable, locally advanced or metastatic small-cell lung cancer\n\n           ⑤ Biliary Tract Cancer: Pathologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma\n\n           ⑥ Hepatocellular carcinoma: pathologically confirmed hepatocellular carcinoma (excluding mixed hepatocellular carcinoma); Barcelona Clinic Liver Cancer (BCLC) stage C, not suitable for radical surgery and\u002For local treatment or stage B without radical progression after surgery and\u002For local treatment; Child-Pugh A liver function; for patients with esophagogastric varices, if gastroscopy or imaging, ultrasound and other examinations suggest severe (G3) varices or positive red sign, indicating high risk of venous bleeding, they are not allowed to participate in this study.\n\n           ⑦ Colorectal cancer: pathologically confirmed unresectable locally advanced or metastatic colorectal cancer\n\n           ⑧ Non-squamous non-small cell lung cancer: pathologically confirmed unresectable locally advanced or metastatic non-squamous non-small cell lung cancer that cannot contain a small cell lung cancer component.\n  4. Willingness to comply with protocol-specified visits, study treatment, laboratory tests, and other study-related procedures and requirements;\n  5. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n  6. Expected survival time of more than 3 months;\n  7. Presence of at least one measurable lesion (non radiation therapy field) confirmed by CT or MRI that meets RECIST v1.1 criteria;\n  8. Adequate organ and bone marrow function:\n\n     Hematologic system (no transfusion, no G-CSF use, no medication for correction within 2 weeks prior to screening): absolute neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL, platelets (PLT) ≥ 75 × 10 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL； Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 × ULN, aspartate aminotransferase (AST) ≤ 3.0 × ULN; for patients with liver metastasis: ALT ≤ 5.0 × ULN, AST ≤ 5.0 × ULN;\n\n     Renal function:\n\n     i. Creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula \\*);\n\n     \\* Formula is: Ccr (ml\u002Fmin) = \\[(140-age) × weight kg × F\\]\u002F\\[serum creatinine (mg\u002Fdl) × 72\\] (F = 1 for males and 0.85 for females) ii. Urine protein \\\u003C 2 + (ie, 0, ± or 1 +) or proteinuria ≤ 1 g\u002F24 hours Note: All patients with ≥ 2 + urine protein in urinalysis must have a 24-hour urine collection and proteinuria ≤ 1 g\u002F24 hours must be confirmed Coagulation: prothrombin time (PT) ≤ 1.5 × ULN or international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n  9. For female patients:\n\n     Females of childbearing potential, who are not breastfeeding, agree to use highly effective contraception from signing the ICF and use this contraception during the study and for 3 months after the last dose; blood pregnancy results (human chorionic gonadotropin hCG) must be negative within 7 days prior to enrollment; Females of non-childbearing potential (ie, physiologically incapable of becoming pregnant), including those surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or postmenopausal for ≥ 12 months prior to Screening (amenorrhea not due to treatment);\n  10. Male patients with female partners of childbearing potential must agree to use highly effective contraception starting from signing the ICF and for the duration of the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Prior use of anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, or other antineoplastic agents containing PD- (L) 1 target;\n  2. Patients who have previously used macromolecular VEGF\u002FVEGFR inhibitors such as bevacizumab, ramucirumab;\n  3. Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies or bispecific antibodies;\n  4. Female patients are pregnant or lactating;\n  5. Major surgery within 4 weeks prior to the first dose of study drug, or planned major surgery within the study period; For primary or metastatic liver cancer: local treatment of liver (such as transarterial chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization or radiofrequency ablation, etc.) within 4 weeks prior to the first dose of study drug;\n  6. Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia and other for which the investigator considers there is no safety risk);\n  7. Patients with clinical symptoms of brain metastases, spinal cord compression, carcinomatous meningitis, or patients with other evidence of uncontrolled brain or spinal cord metastases (except for stable symptoms and imaging studies showing stable disease for at least 4 weeks before the first dose);\n  8. Patients with clinical symptoms or pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n  9. Screening imaging showed tumor encasing vital blood vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk; according to anatomical classification of tumor location, diagnosis of central lung cancer, or tumor involving hilum with bleeding risk.\n  10. Known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive) or acquired immunodeficiency syndrome-related disease;\n  11. Positive hepatitis B surface antigen (HBsAg), and HBV DNA higher than the upper limit of normal value of the detection unit; or positive hepatitis C antibody (HCV-Ab) and HCV-RNA quantification \\> the upper limit of normal value of the detection unit; or known active syphilis infection;\n  12. Uncontrolled bacterial, viral, fungal infections and other pathogen infections (such as mycoplasma, parasites, etc.) requiring systemic treatment within 4 weeks prior to the first dose of study drug;\n  13. History of significant cardiovascular disease, including but not limited to: malignant arrhythmia requiring clinical intervention; or acute coronary syndrome (myocardial infarction and angina pectoris) within 6 months prior to the first dose; or congestive heart failure meeting New York Heart Association (NYHA) functional class II or higher criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50%; poorly controlled hypertension with standard treatment or poor compliance with antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy; and significant vascular disease (eg, aortic aneurysm requiring surgery);\n  14. Patients with coagulation disorders, bleeding disorders, or other conditions judged by the investigator to be at risk of bleeding, such as skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures that have not healed completely, or active gastroduodenal ulcers, gastrointestinal bleeding, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to the first dose;\n  15. Pulmonary hemorrhage\u002Fhemoptysis (daily bleeding\u002Fhemoptysis volume ≥ 2.5ml) within 4 weeks prior to the first dose of study drug;\n  16. Biopsy or other minor surgery within 7 days prior to the first dose of study drug, excluding placement of vascular access devices;\n  17. Arterial or venous thrombosis, or stroke or transient ischemic attack within 6 months prior to the first dose of study drug;\n  18. Unstable anticoagulant or thrombolytic therapy within 14 days of the first dose of study drug;\n  19. Chronic treatment with aspirin (\\> 325 mg\u002Fday) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function, or thienopyridines such as ticlopidine, clopidogrel, or phosphodiesterase inhibitors such as dipyridamole, cilostazol within 14 days of the first dose of study drug;\n  20. Diabetes mellitus not stably controlled by drug therapy; thyroid diseases not stably controlled by drug therapy, such as hyperthyroidism;\n  21. Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc.; severe dyspnea, pulmonary insufficiency or continuous oxygen inhalation for any reason;\n  22. Active autoimmune diseases or history of autoimmune diseases requiring systemic treatment within 2 years before screening, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis or glomerulonephritis; Exceptions: hypothyroidism controlled by hormone replacement therapy alone, dermatologic conditions not requiring systemic therapy (eg, vitiligo, psoriasis), controlled celiac disease;\n  23. Systemic corticosteroid therapy (prednisone \\> 10 mg\u002Fday or equivalent of the same class) or systemic therapy with other immunosuppressive agents within 14 days prior to the first dose of study drug; Exceptions include treatment with topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption, or prophylactic short-term (≤ 7 days) use of corticosteroids (eg, allergy to contrast agents), or for the treatment of non-autoimmune conditions (eg, delayed hypersensitivity caused by contact allergens);\n  24. Received the last systemic anti-tumor therapy (biological agent therapy, etc.) within 4 weeks prior to the first dose, chemotherapy or hormone anti-tumor therapy within 2 weeks prior to the first dose, received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, cyclophosphamide, methotrexate, thalidomide, tumor necrosis factor, etc.) within 2 weeks prior to the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose ;\n  25. Prior organ or hematopoietic stem cell transplant;\n  26. History of other neoplasms within 5 years prior to screening, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, who had undergone successful radical surgery;\n  27. Has received attenuated vaccines within 4 weeks prior to Screening or plans to receive attenuated vaccines during the study;\n  28. Patients who participated in a clinical study and received study drug within 4 weeks prior to the first dose;\n  29. History of alcohol or drug abuse within 12 months prior to the first dose;\n  30. Known psychiatric disorder that could affect trial compliance;\n  31. Other serious systemic diseases or laboratory abnormalities or other reasons considered unsuitable for this study by the investigator.",{"count":358,"type":20},120,[116],"This is a multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of B1962 in the treatment of ad-vanced solid tumors.\n\nThe study consists of a Screening Period, a Treatment Period, and a Follow-up Period (EOT Visit, Safety Follow-up, and Survival Follow-up).\n\nSubjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will enter the appropriate study co-hort according to tumor type and receive B1962 until unacceptable toxicity, radiographic disease progression, or withdrawal of the sub-ject for other reasons, whichever comes first, for a maximum of 24 months of treatment. Enrollment will be conducted according to three stages: Stage I: It is planned to enroll 5 patients in each of 8 cohorts (tumor type) to observe the safety and efficacy; Stage II: 1 \\~ 2 cohorts are preferred to enroll 15 \\~ 20 patients to observe the ef-ficacy and safety; Stage III: 1 cohort is finally preferred to continue enrollment until a total of no more than 60 patients are observed in this cohort to observe the efficacy and safety.",[362,363,364,365,366,367,119],"Recurrent Platinum-resistant Epithelial Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Cervical Cancers","Small Cell Lung Cancer","Hepatocellular Carcinoma (HCC)","Colorectal Cancer","2024-12-04",{"date":370,"type":43},"2024-12-09",{"date":372,"type":20},"2024-12",{"date":374,"type":20},"2026-08",{"name":376,"class":50},"Tasly Biopharmaceuticals Co., Ltd.",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100470262","phase-1-a-study-of-ni-1801-in-patients-with-mesothelin-expressing-solid-cancers-100470262","NCT05403554","A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers","A Phase 1, Open-Label, Dose Finding Study of NI-1801, a Bispecific Mesothelin X CD47 Engaging Antibody, As a Single Agent, in Combination with Anti-PD-1 Antibody, and in Combination with Weekly Paclitaxel (Standard of Care) in Patients with Mesothelin Expressing Ovarian, Pancreatic, Non-Small-Cell-Lung and Triple-Negative Breast Cancers","Main Inclusion Criteria for the Single Agent Dose Escalation and the Combination with Pembrolizumab:\n\n1. Adults ≥ 18 years of age at the time of signing the informed consent form\n2. Histologically or cytologically confirmed diagnosis of epithelial OC (high-grade serous or endometroid), TNBC, or non-squamous NSCLC. For the combination with pembrolizumab, only subjects with histologically or cytologically confirmed diagnosis of epithelial OC (high-grade serous or endometroid), non-squamous NSCLC and ductal pancreatic adenocarcinoma.\n3. MSLN expression with staining intensity of ≥ 2+ as per IHC in ≥ 40% of tumor cells. Staining for MSLN expression can be performed using archival tumor tissue and is foreseen to be performed at the institution's pathology. A slice for centralized IHC assessment for validation and biomarker analysis is mandatory.\n4. Patients with advanced, metastatic, or recurrent disease\n\n   * after at least 1 prior systemic treatment for the primary malignancy and\n   * who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer a clinical benefit to patients with these tumor entities.\n5. Measurable disease according to the revised RECIST guideline version 1.1(3)\n6. Patients treated in either the single agent recommended dose expansion cohort or in the combination with pembrolizumab cohort should have accessible lesions at screening for baseline and on treatment biopsies.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.\n8. Negative pregnancy test at inclusion.\n9. Life expectancy of at least 2 months.\n\nMain Inclusion Criteria for the Randomized study arm:\n\n1. Female patients ≥ 18 years of age.\n2. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer.\n3. Patients must have platinum-resistant disease:\n\n   3.1. Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between greater than 3 months and ≤ 6 months after the date of the last dose of platinum.\n\n   3.2. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum\n4. Patients must have progressed radiographically on or after their most recent line of therapy.\n5. Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of MSLN expression.\n6. MSLN expression with staining intensity of ≥ 2+ as per IHC in ≥ 40% of tumor cells. Staining for MSLN expression can be performed using archival tumor tissue and can be done at the institution's pathology. A slice for centralized IHC assessment for validation and biomarker analysis is mandatory.\n7. Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator).\n8. Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:\n\n   * Adjuvant ± neoadjuvant considered one line of therapy\n   * Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently)\n   * Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (i.e., not counted independently)\n   * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n9. ECOG PS of 0 or 1\n10. Time from prior therapy:\n\n    * Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)\n    * Focal radiation completed at least 2 weeks prior to first dose of study drug\n11. Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities.\n12. Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery.\n13. Patients must have adequate hematologic, liver and kidney functions\n14. Patients or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.\n15. Negative pregnancy test at inclusion\n\nMain Exclusion Criteria for the Single Agent Dose Escalation and the Combination with Pembrolizumab:\n\n1. Patient has known hypersensitivity to NI-1801 or any of the constituent compounds.\n2. Radiotherapy to the target lesions within 4 weeks prior to the first NI-1801 infusion.\n3. Prior anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents within 2 weeks or within ≤ 5 half-lives prior to starting NI-1801 dosing (up to a maximum of 4 weeks), whichever is longer. The maximum required washout period will thus not exceed 4 weeks prior to the day of first treatment with NI-1801. Note: Low dose steroids (oral prednisone or equivalent ≤ 20 mg per day, including systemic or topic use), localized noncentral nervous system (CNS) radiotherapy of non-target lesions, and treatment with bisphosphonates and RANKL inhibitors are not criteria for exclusion.\n4. Other investigational therapies must not be used, i.e., treatment within another clinical trial is not permitted, while the patient is on study. COVID-19 vaccination is allowed only starting from Cycle 2 (if not completed before study inclusion).\n5. Severe cardiac dysfunction (NYHA classification III-IV).\n6. Significant hepatic dysfunction (serum bilirubin ≥ 1.5 mg\u002FdL or AST and\u002For ALT ≥ 2.5 times normal level), unless related to liver metastasis.\n7. Patients with known human immunodeficiency virus (HIV) infection or known history or serological evidence of prior hepatitis B or C virus infection. Active SARS-COV2 infection.\n8. Uncontrolled active systemic bacterial, viral, fungal, or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks prior to first dose of NI-1801.\n9. Patients with concomitant active malignancy, requiring ongoing systemic treatment.\n10. Patients with known CNS metastases.\n11. Platelet count lower than 100 x 10\\^9\u002FL (transfusion support within 14 days before the test is not allowed).\n12. Hemoglobin lower than 10.0 g\u002FdL. Prior RBC transfusion is permitted.\n13. ANC lower than 1 x 10\\^9\u002FL (the use of colony stimulating factors, G-CSF or GM-CSF, within 14 days before the test is not allowed).\n14. Pregnancy and lactation.\n15. History of psychiatric illness or substance abuse likely to interfere with ability to comply with protocol requirements or give informed consent.\n16. Significant medical diseases or conditions, including laboratory abnormalities, as assessed by the Investigators and Sponsor, which would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, and severely immunocompromised state, major surgery ≤ 4 weeks prior to starting NI-1801.\n17. Prior treatment with a CD47, SIRPα, or MSLN targeting agent.\n18. Patients in whom acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure have not resolved to Grade ≤ 1 or returned to baseline except for alopecia (any grade), anemia, and peripheral neuropathy (for the latter, recovery to Grade ≤ 2 is acceptable).\n19. People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship\u002Fcuratorship), people who are unable to express their consent, and people who are subject to a legal guardianship order.\n\nFurthermore, subjects presenting with any of the following criteria will not be included in the sub-study (combination with pembrolizumab cohort):\n\n* History of\u002Factive non-infectious pneumonitis or interstitial lung disease.\n* Known hypersensitivity to pembrolizumab or excipients.\n* Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Prior organ or tissue allograft.\n* History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.\n* History of myocarditis, regardless of etiology.\n\nMain Exclusion Criteria for the Randomized study arm:\n\n1. Patients with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histology, or low-grade or borderline ovarian tumor.\n2. Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.\n3. Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow.\n4. Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:\n\n   * Active hepatitis B or C infection (whether or not on active antiviral therapy)\n   * HIV infection\n   * Active cytomegalovirus infection\n   * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated\n   * Patients with history of multiple sclerosis or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n5. Patients with clinically significant cardiac disease including, but not limited to, any one of the following:\n\n   * Myocardial infarction ≤ 6 months prior to first dose\n   * Unstable angina pectoris\n   * Uncontrolled congestive heart failure (New York Heart Association greater than class II)\n   * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n   * Uncontrolled cardiac arrhythmias\n   * Patients assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan\n   * History of hemorrhagic or ischemic stroke within six months prior to randomization\n6. History of cirrhotic liver disease (Child-Pugh Class B or C)\n7. Previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis\n8. Patients with prior hypersensitivity to monoclonal antibodies.\n9. Women who are pregnant or lactating.\n10. Patients with prior treatment with a CD47, signal regulatory protein (SIRP) alpha, or MSLN targeting agent.\n11. Patients with central nervous system (CNS) metastases.\n12. Patients with a history of other malignancy within 3 years prior to randomization.\n13. Prior known hypersensitivity reactions to study drugs and\u002For any of their excipients.",{"count":385,"type":20},70,[148],"Study LCB-1801-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NI-1801 in patients with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN).\n\nThe dose escalation part (Part A) of the main study will evaluate the safety and tolerability of escalating doses of NI-1801 to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of NI-1801. The expansion part (Part B) of the main study will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 10 additional subjects in order to determine the recommended Phase 2 dose (RP2D).\n\nTreatments will be administered in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator\u002Fpatient decision to withdraw study consent.\n\nThe dose escalation part (Part A) of the sub-study will evaluate the safety and tolerability of escalating doses of NI-1801 in combination with anti-PD-1 antibody. The expansion part (Part B) of the sub-study will further evaluate the safety and efficacy of NI-1801 administered in combination with anti-PD-1 antibody at or below the MTD.\n\nIn the randomized cohort, the experimental arm will receive the investigational drug NI-1801 at the P2RD every two weeks in combination with weekly administration of paclitaxel (80 mg\u002Fm\\^2) over 4-week cycles. The control arm will be treated with weekly paclitaxel at the same regimen representing one of the standards of care (SoC) in this population. This trial specifically targets patients with platinum-resistant ovarian cancer. This cohort will be made up of 20 evaluable patients, 10 per arm.",[389,390,391,392,393],"Epithelial Ovarian Cancer","Triple Negative Breast Cancer","Non-squamous Non-small-cell Lung Cancer","Pancreatic Adenocarcinoma (ductal Adenocarcinoma)","Endometrioid Ovarian Cancer","2024-10-25",{"date":396,"type":43},"2024-10-29",{"date":398,"type":43},"2022-04-29",{"date":400,"type":20},"2026-09-30",{"name":402,"class":50},"Light Chain Bioscience - Novimmune SA",7,{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":178,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":105},"100541860","phase-2-a-phase-iiiii-study-of-adebrelimab-in-combination-with-shr-8068-and-chemotherapy-in-advanced-or-metastatic-nsclc-patients-100541860","NCT06335355","A Phase II\u002FIII Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients","A Phase II\u002FIII, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11\u002FKEAP1\u002FKRAS Mutations","Inclusion Criteria:\n\n1. The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.\n2. At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.\n3. Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.\n4. At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .\n5. The participant is expected to have a life expectancy of at least 12 weeks.\n6. Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.\n7. The participant must have adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.\n2. Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.\n3. Subjects with spinal cord compression that has not been radically treated by surgery and\u002For radiotherapy.\n4. Subjects with inadequately controlled pain related to their tumor(s).\n5. Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.\n6. Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.\n7. Subjects whose toxicities and\u002For complications from previous interventions have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) Grade ≤1.\n8. Subjects participating in another clinical study or whose initiation of study treatment is less than 4 weeks since the end of the last clinical study (last dose administration), or less than five half-lives of that study drug, whichever is shorter.\n9. Subjects who have received systemic immunostimulant treatment within 4 weeks prior to starting the study treatment.\n10. Subjects who have received systemic immunosuppressive treatment within 2 weeks prior to starting the study treatment.\n11. Subjects with any active, known, or suspected autoimmune disease.\n12. Subjects with severe heart disease.\n13. Subjects who have experienced arterial or venous thrombotic events within 3 months prior to starting the study treatment.\n14. Subjects with active syphilis infection.\n15. Subjects who have had a severe infection within 4 weeks prior to starting the study treatment.\n16. Subjects who have previously undergone or are planning to undergo allogeneic hematopoietic stem cell transplantation or organ transplantation.\n17. Subjects with a history of severe hypersensitivity reactions to other monoclonal antibodies.\n18. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n19. Subjects with a history of substance abuse of psychoactive drugs, alcoholism, or drug addiction.\n20. Subjects whom the investigator believes have any medical condition (such as pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric conditions, or social circumstances that could potentially interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate, and participate in the study, or interfere with the assessment of the investigational drug, interpretation of subject safety data, or study results.",{"count":412,"type":20},401,[116,23],"Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11\u002FKEAP1\u002FKRAS Mutations",[26],"2024-03-21",{"date":418,"type":43},"2024-03-28",{"date":420,"type":20},"2024-03",{"date":422,"type":20},"2030-10",{"name":424,"class":50},"Shanghai Shengdi Pharmaceutical Co., Ltd",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":432,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":448},"100503915","phase-2-anti-pd-1-antibody-therapies-of-camrelizumab-in-combination-with-pemetrexed-and-carboplatin-as-first-line-treatment-in-patients-with-advanced-or-metastatic-non-squamous-non-small-cell-lung-cancer-100503915","NCT05841472","Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","An Open-label, Multi-center, Clinical Study to Evaluate Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Subject aged between 19-80 at the time of signing the informed consent form, male or female.\n2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), Stage IIIB-IV (as per the International Association for the Study of Lung Cancer (IASLC) Staging Handbook in Thoracic Oncology, 8th Edition).\n3. The site must provide documented information on EGFR mutation and ALK translocation and both must be negative. Subject cannot be randomized before receiving the source document for EGFR mutation and ALK translocation.\n4. A tumor tissue specimen collected upon or after diagnosis of advanced or metastatic disease, either fresh or archival (within 6 months prior to the first dose), must be provided. At least 10 unstained slides can be generated from the formalin fixed, paraffin-embedded (FFPE) tumor tissue block for immunohistochemistry assay or biomarker testing (or may be less than 10 slides as approved by the sponsor's medical monitor). Specimen obtained from fine needle aspiration, pleural fluid smear, or drill biopsy are unacceptable. For bone lesions, specimen without soft tissue components or decalcified bone tumor specimen is also unacceptable.\n5. Subjects who have not previously received systemic chemotherapy for advanced\u002Fmetastatic NSCLC. Chemotherapy as neo-adjuvant\u002Fadjuvant therapy or chemoradiotherapy is permitted, as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease.\n6. Radiographically measurable lesions via CT or MRI, as per RECIST 1.1. The tumor assessment of baseline should be performed within 28 days prior to the first dose.\n7. ECOG PS score: 0-1.\n8. Expected survival ≥ 3 months.\n9. Subjects must undergo all screening laboratory tests as per the protocol within 14 days prior to the first dose. Laboratory tests at screening must meet the following criteria:\n\n1\\) Hematology: (without blood transfusion, G-CSF, or medication within 14 days prior to screening)\n\n1. Hemoglobin (HB) ≥ 90 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL;\n3. Platelet (PLT) ≥ 100 x 109\u002FL;\n4. White blood cell (WBC) ≥ 4.0 x 109\u002FL and ≤ 15 x 109\u002FL; 2) Biochemistry: (no blood or albumin transfusion within 14 days prior to screening)\n5. AST and ALT ≤ 1.5 x ULN (≤ 5 x ULN for liver metastasis);\n6. ALP ≤ 2.5 x ULN (≤ 5 x ULN for bone metastasis);\n7. TBIL ≤ 1.5 x ULN;\n8. ALB ≥ 30 g\u002FL;\n9. Cr ≤ 1.5 x ULN, and creatinine clearance (CrCL) ≥ 60 mL\u002Fmin (Cockcroft-Gault equation);\n10. APTT ≤ 1.5 x ULN, and INR or PT ≤ 1.5 x ULN (no anticoagulant therapy).\n\n    10\\. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use adequate method of contraception during the study period and 180 days after the last dose of study medication.\n\n    11\\. Subject has voluntarily agreed to participate by giving written informed consent\u002Fassent.\n\n    Exclusion Criteria:\n\n    1\\. Exclusion criteria for the target indication\n    1. Subjects with other histological types besides non-squamous non-small cell lung cancer, including mixed carcinomas or NSCLC with small cell lung cancer components\u002Fneuroendocrine differentiation.\n    2. Subjects with EGFR mutation or ALK translocation.\n    3. Subjects without radiographically measurable lesions.\n    4. Subjects with carcinomatous meningitis and spinal cord compression.\n    5. Subjects with untreated central nervous system (CNS) metastasis. Subjects with previously treated CNS metastases may participate if the CNS metastasis is limited to the supraentorial and cerebellar regions, adequately treated, and clinically stable (by radiological tumor assessments, preferably enhanced MRI or CT) for at least 4 weeks, and if the subject's neurological symptoms can return to NCI-CTCAE Grade ≤ 1 within 2 weeks prior to the first dose. In addition, subjects who are using corticosteroids for clinical symptoms are not eligible, unless the doses of corticosteroids stable or gradually reduced to prednisone ≤ 10 mg\u002Fday (or equivalent) -for at least 2 weeks.\n    6. Subjects who can be treated with surgical resection or radical radiotherapy.\n    7. Subjects who previously received treatment with any other anti-PD-1(L1) or CTLA4 monoclonal antibodies.\n\n    2\\. Medical history and complications\n    1. Subjects with any active, known, or suspected autoimmune diseases. Subjects who are clinically stable and do not require systemic immunosuppressants, such as those with Type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases that do not require systemic treatment (for example, vitiligo, psoriasis or alopecia), or subjects in whom recurrence are not expected without external triggers may be eligible.\n    2. Subjects with any complication that require systemic corticosteroids like prednisone (\\> 10 mg\u002Fday or equivalent) or other immunosuppressants within 14 days prior to the first dose. In the absence of active autoimmune disease, inhaled or topical use of corticosteroids, and physiologic hormone replacement therapy for adrenal insufficiencylike prednisone \\> 10 mg\u002Fday or equivalent are permitted;\n    3. Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose.\n    4. Subjects who are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks (or 5 half-lives of the previous investigational agent) prior to the first dose.\n    5. Subjects who are expected to require any other forms of anti-cancer treatment (including maintenance treatment with other drugs, radiotherapy, and\u002For surgical resection) for NSCLC while on study.\n    6. Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy \\> 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy \\> 30 Gy within 24 weeks prior to the first dose, or palliative radiation ≤ 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and\u002For complications of these interventions to NCI-CTC AE Grade ≤ 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to the first dose and no additional radiotherapy should be scheduled for the same lesion.\n    7. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function.\n    8. Subjects who require concomitant treatment for other active malignant tumors.\n    9. Subjects with a history of prior malignant tumors, except for basal cell carcinoma, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ with complete remission for at least 5 years prior to screening and no additional treatment is required or expected while on study.\n    10. Subjects with Grade II or higher myocardial ischemia or myocardial infarction, or poorly controlled arrhythmias. Subjects with NYHA Class III-IV cardiac insufficiency or an LVEF (left ventricular ejection fraction) \\\u003C 50% by echocardiography.\n    11. Subjects with significant hemoptysis or coughing a daily volume up to half a teaspoon (2.5 mL) or more of blood within 1 month prior to randomization.\n    12. Subjects with clinically significant hemorrhage or clear bleeding tendency within 1 month prior to randomization, such as GI bleeding, hemorrhagic gastric ulcer, or vasculitis.\n    13. Events of arterial\u002Fvenous thrombosis within 3 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, brain infarction), deep vein thrombosis, and pulmonary embolism.\n    14. Subjects with active pulmonary tuberculosis (TB). Active TB should be ruled out in subjects suspected of such condition, by chest X-ray, sputum test, and examinations of clinical symptoms and signs. Subjects with a history of active TB infection within 1 year prior to the screening are excluded, despite being treated. Subjects with a history of active TB infection more than 1 year ago can be enrolled if the course and type of TB treatment are appropriate.\n    15. Subjects with serious infection within 4 weeks prior to the first dose, including but not limited to infective complications, bacteremia and severe pneumonia that require hospitalization. Subjects with any active infections are excluded, lymphangitic spread of the NSCLC is not exclusionary.\n    16. Subjects who prepare to receive or have previously received tissue\u002Forgan transplants.\n    17. Subjects who plan to receive or have received live vaccines within 30 days prior to the first dose.\n    18. Subjects with contraindications for platinum-based medications before the first dose: gout, varicella, herpes zoster, and Grade ≥ 2 peripheral neuropathy.\n    19. It is not recommended to enroll subjects with uncontrolled tumor-related pain. Subjects requiring pain medication must have a stable regimen before randomization. Palliative radiotherapy for symptomatic lesions (such as bone metastasis or perineural invasion) should be completed at least 2 weeks before enrollment. Loco-regional treatment should be considered before randomization, if appropriate, for asymptomatic metastatic lesions where further growth may result in functional deficits or intractable pain (e.g., epidural metastasis without spinal cord compression).\n\n    3\\. Physical examination and laboratory tests\n    1. Subjects have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS).\n    2. Subjects with untreated active hepatitis. Hepatitis B: Hepatitis B surface antigen (HBV sAg) positive and HBV DNA greater than the upper limit of normal; Hepatitis C: HCV antibody (HCV Ab) positive and HCV RNA positive, and abnormal hepatic function; Hepatitis B and C coinfection.\n    3. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n\n    4\\. Allergies and adverse drug reactions\n    1. Severe allergic, anaphylactic, or other hypersensitivity reactions to other monoclonal antibodies.\n    2. Allergy or intolerance during an infusion.\n    3. History of severe allergies to pemetrexed, carboplatin, or their premedications.\n\n    5\\. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n    6\\. Based on the investigator's opinion, subjects with a history or current evidence of any condition, diseases, treatments, or laboratory abnormalities that may confound the study results, interfere with study procedures, or are not in the best interests of the subjects, should be excluded.","19 Years","80 Years",{"count":435,"type":20},60,[116],"The objective of this bridging study is to acquire new drug approval in Korea for camrelizumab (SHR-1210), a drug that has already been approved in China for treatment in patients with histologically or cytologically confirmed advanced or metastatic (Stage IIIB-IV), EGFR\u002FALK wild-type, non-squamous, non-small cell lung cancer. In this study, subjects with advanced or metastatic, EGFR\u002FALK wild-type, non-squamous, non-small lung cancer will receive anti-PD-1 antibody therapy of camrelizumab in combination with pemetrexed + carboplatin as first-line treatment for at least 8 cycles (24 weeks). Then, the best overall RECIST responses (BOR) from subjects who have had at least 1 post-baseline tumor assessment will be evaluated to confirm that camrelizumab, a drug that has already been approved China, has similar efficacy in the Korean population as in the Chinese population.",[156],"2023-08-28",{"date":441,"type":43},"2023-08-30",{"date":443,"type":43},"2023-08-23",{"date":445,"type":20},"2026-12",{"name":447,"class":50},"CrystalGenomics, Inc.",8,{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":16,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":473,"leadSponsor":474,"locationsCount":4},"100513173","phase-2-neoadjuvant-toripalimab-for-non-squamous-nsclc-with-egfr-mutation-100513173","NCT05962021","Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation","Neoadjuvant Toripalimab Plus Chemotherapy for Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation: a Multicentre, Multi-cohort, Exploratory Study.","Inclusion Criteria:\n\n1. Provision of signed informed consent by the patient or legally acceptable representative;\n2. Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;\n3. Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;\n4. Harboring EGFR mutation (19del or L858R);\n5. Aged 18-70 years, regardless of gender;\n6. Eastern Cooperative Group (ECOG) Performance Status 0-1;\n7. Acceptable cardiac function with a left ventricular ejection fraction \\>50%;\n8. Acceptable respiratory function (FEV1\\>1.5L, DLCO\\>50%) and ability to tolerate radical lung cancer surgery;\n9. Acceptable bone marrow haematopoiesis with leucocytes ≥ 4 x 10\\^9\u002FL, neutrophils ≥ 1.5 x 10\\^9\u002FL, haemoglobin ≥ 10g\u002FdL and platelets ≥ 100 x 10\\^9\u002FL;\n10. Acceptable renal function with a glomerular filtration rate ≥ 60 mL\u002Fmin;\n11. Acceptable liver function with total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, and ALT ≤ 3 x ULN;\n12. Presence of measurable lesions as defined by RECIST 1.1 criteria;\n13. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 3 days prior to the start of study treatment, and agree to use effective contraception for the duration of study drug use and for 120 days after the last dose. Women of childbearing potential were defined as sexually mature females who 1) had not undergone hysterectomy or bilateral oophorectomy and 2) had not experienced spontaneous menopause for 12 consecutive months (amenorrhea after cancer treatment did not preclude fertility) (menstruation had occurred at any time during the previous 12 consecutive months).\n\nExclusion Criteria:\n\n1. Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;\n2. Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;\n3. Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;\n4. Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA \\\u003C500 IU\u002Fml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;\n5. Patients who are allergic to chemotherapeutic agents such as carboplatin, paclitaxel, albumin paclitaxel, pemetrexed;\n6. Patients with a history of allergy to monoclonal antibody drugs;\n7. Patients who have previously received an allogeneic stem cell transplant or organ transplant；\n8. Patients with mental illness or any other illness that makes it impossible to comply with treatment；\n9. Patients who are unable or unwilling to sign the informed consent form；\n10. Patients with comorbidities or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or make them unsuitable for participation in this study.","17 Years","70 Years",{"count":459,"type":20},126,[116],"This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.",[156,463],"EGFR Positive Non-small Cell Lung Cancer",[465,466,467,468],"Non squamous non small cell lung cancer","EGFR Mutation","Neoadjuvant immuno-chemotherapy","Predictive and prognostic biomarker","2023-07-28",{"date":471,"type":43},"2023-08-01",{"date":471,"type":20},{"date":72,"type":20},{"name":475,"class":193},"Peking University People's Hospital","Non-Squamous Non-Small-Cell Lung Cancer"]