[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,43,79,128,150,172,199,231,259,288,316,338,359,382,405,429,446,464,483,503],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644763","early-phase-1-a-clinical-study-gk01-cell-injection-in-subjects-with-advanced-lung-cancer-100644763",false,"NCT07673419","A Clinical Study GK01 Cell Injection in Subjects With Advanced Lung Cancer","A Single-Arm Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants With Advanced Lung Cancer","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent document.\n* At the date of signing ICF, 18 \\~75 years old, male or female.\n* Histologically or cytologically confirmed recurrent, or metastatic advanced lung cancer, progressed on standard treatment, or intolerant to standard treatment.\n* At least one measurable lesion that has not been irradiated or received other local therapies.\n* At least one measurable lesion remains (RECIST 1.1 criteria).\n* ECOG 0-1 points.\n* Expected survival time more than 3 months.\n* Adequate hematologic and organ function.\n* No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.\n\nExclusion Criteria:\n\n* History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).\n* Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.\n* Major surgery within 28 days prior to signing the ICF, or planned during the study period.\n* Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.\n* Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.\n* History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.\n* Prior history of bone marrow or organ transplantation.\n* Concurrent or prior history of interstitial lung disease or interstitial pneumonia.\n* History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).\n* History of other primary malignancies within 5 years prior to the initiation of the study treatment.\n* Clinically significant cardiovascular disease.\n* History of bleeding within 6 months prior to signing the ICF.\n* Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \\[HbA1c\\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and\u002For uncertainty in survival assessment.\n* Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.\n* Live\u002Fattenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live\u002Fattenuated or inactivated vaccine during the screening period.\n* Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg\u002Fday of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.\n* Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.\n* Female subjects who are pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer",[27],"Advanced Lung Cancer",[29,27],"GK01 Cell Injection","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-29","ACTUAL",{"date":36,"type":21},"2026-07",{"date":38,"type":21},"2028-07",{"name":40,"class":41},"Beijing Geekgene Technology Co., LTD","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100584684","phase-1-a-clinical-study-to-investigate-the-efficacy-and-safety-of-an-investigational-combination-therapy-with-bnt324-and-bnt327-in-patients-with-advanced-lung-cancer-100584684","NCT06892548","A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer","A Phase Ib\u002FII, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at the time of giving informed consent.\n* Histological or cytological confirmed unresectable advanced\u002Fmetastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.\n\n  * Part 1: Participants with NSCLC and SCLC\n  * Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L\n  * Part 2 Cohort 2: Participants with SCLC, 2L+\n  * Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+\n  * Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L\n  * Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+\n  * Part 2 Cohort 6: Participants with NSCLC AGA positive\n  * Part 2 Cohort 7: Participants with SCLC, 1L\n* Have measurable disease defined by RECIST version 1.1.\n* Have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a life expectancy of ≥12 weeks.\n\nExclusion Criteria:\n\n* Prior treatment with B7-H3 targeted therapy.\n* Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line\u002Ftreatment-naïve cohorts in the advanced\u002Fmetastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced\u002Fmetastatic setting.\n* Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as \"radical\" intent), per investigator's assessment.\n* Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent\u002Fpersistent Grade 3 to 4 neutropenia.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply to all or some participants depending on the cohort.",{"count":51,"type":21},594,[53,54],"PHASE1","PHASE2","This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced\u002Fmetastatic or relapsed\u002Fprogressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).",[27],[58,59,60,61,62,63,64,65,66,67,68],"Small cell lung cancer (SCLC)","Non-small cell lung cancer (NSCLC)","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor (VEGF)","Bispecific antibody","BNT324 (DB-1311)","BNT327","Combination with chemotherapy","Combination with other investigational agents","Immunotherapy","Treatment-naïve","RECRUITING",{"date":71,"type":34},"2026-06-24",{"date":73,"type":34},"2025-05-02",{"date":75,"type":21},"2032-05",{"name":77,"class":41},"BioNTech SE",86,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":101,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":87,"type":21},392,[53],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[91,92,93,94,95,96,97,98,27,99,100],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","2026-06-18",{"date":31,"type":34},{"date":122,"type":34},"2024-10-29",{"date":124,"type":21},"2028-11",{"name":126,"class":41},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100616720","phase-2-a-phase-ii-clinical-study-evaluating-the-combination-therapy-of-js212-in-patients-with-advanced-lung-cancer-100616720","NCT07309276","A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. The age between 18 and 75 years old, and any gender.\n2. Local advanced, metastatic or recurrent NSCLC.\n3. ES-SCLC.\n4. According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), there must be at least one measurable lesion.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Expected survival period of ≥ 12 weeks.\n7. The functions of important organs meet the requirements.\n8. Female participants with reproductive capacity (WOCBP) who have sexual life with an unsterilized male partner and who have signed the informed consent must have a negative serum pregnancy test result within 7 days before the first administration, and must agree to take effective contraceptive measures from the time of signing the ICF until 7 months after the last administration of the study.\n9. Unsterilized male participants who have sexual life with a fertile female partner must agree to use the effective contraceptive measures after signing the ICF until 4 months after the last administration of the study. During this period, sperm donation is prohibited.\n10. The participants voluntarily participate in this study and sign the informed consent.\n\nExclusion Criteria:\n\n1\\. Accompanying the following disease states:\n\n1. Tumor histological or cytological pathological confirmation of combined large cell neuroendocrine carcinoma or sarcomatoid lesion, or NSCLC with small cell lung cancer component;\n2. NSCLC patients with positive driver mutations;\n3. Patients with known meningeal metastasis;\n4. Patients with symptomatic brain metastases;\n5. Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites;\n6. Unatable spinal cord compression;\n\n2\\. Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:\n\n1. Within one month before the first use of the study drug, any clinically significant hemoptysis or tumor bleeding;\n2. High bleeding risk; tumor invading important organs, high risks of perforation, esophageal-tracheal fistula, massive hemoptysis, etc.;\n3. Obvious bleeding tendency or severe coagulation dysfunction history, etc;\n4. Recent gastrointestinal perforation, gastrointestinal obstruction, trachea-esophageal fistula, abdominal fistula or intra-abdominal abscess, or currently having high-risk factors for hollow organ perforation\u002F fistula formation, or active inflammatory bowel disease, etc;\n5. Presence of severe, non-healed or open wounds, active ulcers or untreated fractures;\n6. Have poorly controlled hypertension;\n7. Have used antiplatelet drugs or anticoagulant therapy within 14 days;\n8. Have experienced a drug-related adverse event that led to permanent discontinuation of the medication during previous Bevacizumab and similar agent treatments;\n\n3\\. Have received any of the following treatments:\n\n1. Immune-mediated treatments (only for part Two);\n2. Have received any investigational drug within 4 weeks or 5 half-lives before the first use of the study drug;\n3. Have been enrolled in another clinical study;\n4. Have undergone major surgery within 4 weeks;\n5. Have received local small-scale radiotherapy within 14 days;\n\n4.Have not recovered to ≤ CTCAE grade 1 toxicity or the level specified in the inclusion\u002Fexclusion criteria.\n\n5.Have known allergies to any study treatment or its excipients or have experienced an allergic reaction.\n\n6.Have experienced a drug-related AE that led to permanent discontinuation of the anti-PD-(L)1 antibody treatment.\n\n7.Have any of the following cardiac examination results:\n\n1. Long QT;\n2. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n8.Have a history of diagnosed or suspected ILD, drug-induced pneumonia, or other severe lung diseases.\n\n9.Have experienced a severe infection within 4 weeks.\n\n10.Have a history of immunodeficiency, or have a history of organ transplantation and allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n\n11.Have active pulmonary tuberculosis infection.\n\n12.Have active hepatitis.\n\n13\\. Uncontrolled concurrent diseases.\n\n14\\. Participants who were diagnosed with any other malignant tumor within 5 years.\n\n15\\. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n\n16\\. Other conditions for trial participation were not considered appropriate by the investigator.",{"count":135,"type":21},864,[54],"This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.",[27],"2026-05-14",{"date":141,"type":34},"2026-05-18",{"date":143,"type":34},"2026-01-23",{"date":145,"type":21},"2028-11-11",{"name":147,"class":148},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",1,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100621200","phase-1-a-clinical-trial-on-the-efficacy-and-safety-of-tqb6411-for-injection-100621200","NCT07367529","A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection","A Phase Ib\u002FII Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance;\n* Age between 18 and 75 years (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Expected survival greater than 12 weeks;\n* At least one measurable lesion according to RECIST v1.1 criteria;\n* Laboratory test results meeting the following criteria (no blood transfusion within 14 days or hematopoietic growth factor administration within 7 days prior to screening):\n\n  1. Hemoglobin (HGB) ≥ 90 g\u002FL;\n  2. Absolute neutrophil count (NEUT) ≥ 1.5×10⁹\u002FL;\n  3. Platelet count (PLT) ≥ 90×10⁹\u002FL;\n  4. Total bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN);\n  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN if liver metastases are present);\n  6. Serum creatinine (CR) ≤ 1.3×ULN or creatinine clearance rate (CCR) ≥ 50 mL\u002Fmin;\n  7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy within the past 2 weeks);\n* Lung cancer confirmed by histology or cytology；\n* Willing to provide qualified tumor tissue samples for immunohistochemical testing, unless the subject has no eligible archived specimens and is unsuitable or refuses re-biopsy;\n* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with a negative serum or urine pregnancy test within 7 days before enrollment; male subjects must agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).\n\nExclusion Criteria:\n\n* History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)\\].\n* Diseases affecting intravenous injection or blood sampling.\n* Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.\n* Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds\u002Ffractures.\n* Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose.\n* Arterial\u002Fvenous thromboembolic events within 6 months prior to first dose, including: cerebrovascular accidents (including transient ischemic attack (TIA), excluding lacunar infarction), deep vein thrombosis, or pulmonary embolism (implantable venous port- or catheter-related thrombosis or superficial venous thrombosis not considered \"severe\" thromboembolism).\n* Active viral hepatitis with poor control, except: hepatitis B surface antigen (HBsAg)-positive subjects with Hepatitis B virus Deoxyribonucleic acid (HBV DNA) \\\u003C500 IU\u002FmL (2500 copies\u002FmL) who agree to receive anti-HBV therapy throughout study; or hepatitis C virus (HCV)-infected subjects (Hepatitis C Virus Antibody or Ribonucleic Acid positive) with hepatitis C virus Ribonucleic Acid (HCV RNA) ≤ULN continuing approved antiviral therapy.\n* Active syphilis requiring treatment.\n* Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced\u002Fradiation pneumonitis requiring treatment, clinically significant active pneumonia, history of interstitial lung disease (ILD) requiring treatment, or current ILD.\n* History of psychotropic drug abuse or mental disorders.\n* Prior or planned allogeneic bone marrow or solid organ transplantation.\n* History of hepatic encephalopathy.\n* Significant cardiovascular diseases including:\n\n  1. Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) \\\u003C50% by echocardiography;\n  2. Clinically significant ventricular arrhythmia history (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic therapy (subjects with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment);\n  3. Unstable angina;\n  4. Myocardial infarction within 12 months;\n  5. Cardio contraction time (QTc) \\>450ms (male) or \\>470ms (female) (if abnormal, measure three times at ≥2-minute intervals and average; corrected by Fridericia or Bazett method);\n  6. Congenital long QT syndrome or family history.\n* Active or uncontrolled severe infection (≥CTCAE grade 2).\n* Renal failure requiring hemodialysis or peritoneal dialysis.\n* Immunodeficiency including HIV positivity or other acquired\u002Fcongenital immunodeficiency diseases.\n* Uncontrolled autoimmune diseases requiring immunosuppressants or systemic corticosteroids (\\>10mg prednisone\u002Fday equivalent) within 7 days prior to first dose.\n* Epilepsy requiring treatment.\n* Poorly controlled diabetes (fasting blood glucose \\>10mmol\u002FL).\n* Tumor-related conditions and treatments:\n\n  1. Chemotherapy, immunotherapy, or small-molecule targeted therapy within 3 weeks prior to first dose or within 5 half-lives (whichever shorter); prior local radiotherapy allowed if: completed \\>4 weeks (\\>2 weeks for brain) before study treatment, and target lesions are outside radiation field or show progression within field;\n  2. National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose;\n  3. Tumor invading major vessels or judged likely to cause fatal hemorrhage;\n  4. Uncontrolled effusions\u002Fascites requiring recurrent drainage;\n  5. Spinal cord compression, leptomeningeal metastases, or brain metastases with symptoms controlled \\\u003C4 weeks, or requiring steroids\u002Fdehydrating agents within 2 weeks before treatment.\n* Known hypersensitivity to study drug or excipients.\n* Prior treatment with: Epidermal Growth Factor Receptor\u002Fcellular-mesenchymal epithelial transition factor (EGFR\u002Fc-Met)-targeted antibody-drug conjugates (ADCs); or topoisomerase I inhibitors (Non-Small Cell Lung Cancer only) or topoisomerase I inhibitor-based ADCs.\n* Prior EGFR\u002Fc-Met-targeted Monoclonal Antibody (mAbs)\u002Fbispecifics with: ≥grade 4 toxicity, permanent discontinuation due to toxicity, ≥grade 3 infusion reactions, or ≥grade 3 myalgia.\n* Participation in other antitumor clinical trials within 4 weeks prior to first dose.\n* Other conditions judged by investigator to jeopardize subject safety or study completion.",{"count":158,"type":21},465,[53,54],"To evaluate the efficacy and safety of TQB6411 for Injection in subjects with advanced lung cancer",[27],"2026-04-29",{"date":164,"type":34},"2026-05-05",{"date":166,"type":34},"2026-02-26",{"date":168,"type":21},"2028-12",{"name":170,"class":41},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",37,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":149},"100610441","a-digital-health-intervention-to-improve-physical-function-and-wellness-of-lung-cancer-survivors-100610441","NCT07227623","A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors","Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of stage I-III non-small cell lung cancer\n* Within six weeks of initiating treatment with curative intent that includes chemotherapy ± immunotherapy in the neo-adjuvant or adjuvant setting with surgery or as part of definitive chemoradiation\n* Eastern Cooperative Oncology Group Performance Status = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours)\n* Ability to use a digital health intervention that includes verbal and written information in English\n* Ability to complete questionnaires in English or Spanish\n* Primary cancer care at one of the participating institutions\n\nExclusion Criteria:\n\n* Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures",{"count":180,"type":21},250,[182],"NA","The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. However, the survivorship needs of this population are considerable and too often overlooked, especially with respect to their health behaviors, such as physical activity and nutrition, as well as persistent symptoms and side effects, including breathing difficulties and sleep disturbance. To ensure that as many patients as possible can access the information, support, and skills they require to navigate the diagnosis and treatment of lung cancer, the investigators worked with a multidisciplinary team to create a digital health intervention, called \"PROMOTE.\" The investigators designed the PROMOTE mobile app for lung cancer survivors undergoing treatment to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing. To achieve the long-term goal to have PROMOTE become widely available to all lung cancer survivors, the next step in this research program is to conduct a randomized trial to demonstrate the benefits of the digital health intervention. Specifically, the investigators hypothesize that, compared to patients receiving enhanced usual care, those assigned to PROMOTE will report improved physical function, less difficulty with breathlessness and sleep disturbance, increased physical activity, healthier eating behaviors, fewer symptoms of anxiety and depression, and better quality of life. The investigators also plan to examine whether PROMOTE leads to more effective coping and greater confidence in patients' ability to manage their health (i.e., self-efficacy). For this project, the investigators will enroll lung cancer survivors receiving care at an academic cancer center and two affiliated community sites that provide care for diverse patient populations to ensure the results apply to a wide range of individuals with lung cancer. Participants will be randomly assigned either to receive the PROMOTE app intervention for 12 weeks or to an enhanced usual care control group that includes health education materials. Participants will complete surveys at enrollment and again at 6, 12, and 24 weeks after enrollment. At the end of the study, those assigned to the control group will be permitted to receive the PROMOTE app as well.",[27,185],"Physical Function",[187,188,189,185],"Lung Cancer","Behavioral Intervention","Digital Health App","2026-03-17",{"date":192,"type":34},"2026-03-19",{"date":194,"type":34},"2026-02-06",{"date":196,"type":21},"2029-02-28",{"name":198,"class":148},"Massachusetts General Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":215,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":149},"100558781","engage-psychosocial-intervention-for-cancer-symptoms-100558781","NCT06555588","Engage Psychosocial Intervention for Cancer Symptoms","Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer","Engage","Inclusion Criteria:\n\n* Receiving cancer care at 1) a Duke Cancer Network (DCN) clinic; or 2) the Duke Cancer Institute (DCI) and live in a rural county at least 60 miles from Duke\n* Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer\n* Worst pain, fatigue, or distress rated at \\>\u002F= 3 out of 10 in the past 7 days for at least 2 symptoms\n* MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \\>\u002F= 3 out of 10 in the past 7 days\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower\n* At least 18 years old\n* Ability to speak and read English\n* Hearing and vision that allows for successful completion of telehealth sessions\n\nExclusion Criteria:\n\n* Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire\n* Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation\n* Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management\n* Enrollment in hospice at screening",{"count":208,"type":21},190,[182],"The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.",[93,212,27,213,214],"Advanced Prostate Cancer","Advanced Colorectal Carcinoma","Advanced Colorectal Adenocarcinoma",[216,217,218,219,220,221,222],"Acceptance and Commitment Therapy","Cognitive Behavioral Therapy","Pain management","Fatigue management","Symptom management","Telehealth","Psychosocial intervention","2026-03-12",{"date":225,"type":34},"2026-03-16",{"date":227,"type":34},"2025-06-11",{"date":124,"type":21},{"name":230,"class":148},"Duke University",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100624153","evaluation-of-the-effectiveness-of-managing-chemotherapy-side-effects-using-epro-and-a-standardized-telenursing-program-for-cancer-patients-100624153","NCT07405931","Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Diagnosed with early or advanced gastric, lung, breast, or colon cancer\n* Starting first-cycle chemotherapy with a new anticancer agent\n* Able to use a smartphone without difficulty\n* Willing to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons\n* Individuals who cannot read, write, or understand Korean\n* Other individuals deemed inappropriate for participation by the investigators","19 Years",{"count":239,"type":21},414,[182],"This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.",[243,244,245,27,246,93,247,248],"Early Gastric Cancer","Advanced Gastric Cancer","Early Lung Cancer","Early Breast Cancer","Early Colon Cancer","Advanced Colon Cancer","2026-02-08",{"date":251,"type":34},"2026-02-12",{"date":253,"type":34},"2025-07-09",{"date":255,"type":21},"2026-09",{"name":257,"class":148},"Ulsan University Hospital",5,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":258},"100623078","tier-palliative-care-for-patients-with-advanced-heart-failure-or-cancer-100623078","NCT07391956","Tier Palliative Care For Patients With Advanced Heart Failure or Cancer","TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer","TIER-PC","Inclusion Criteria:\n\n* Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or\n* Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) or tripe negative breast cancer with one hospitalization within the last 6 months\n* KPS \\> or = 50% (ECOG 0, 1 or 2)\n* \\> 2 outpatient MSHS visits in prior 12 months\n* Manhattan or Queens residence\n* Capacity to provide informed consent\n* English or Spanish fluency\n* \\> or = 18 years of age\n\nExclusion Criteria:\n\n* Diagnoses of both cancer and advanced HF\n* Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory\n* Patients with \\> 1 visit to Outpatient Supportive Oncology\u002FCardiology visit\n* Patients with last visit to Outpatient Supportive Oncology\u002FCardiology \\\u003C 3 months ago\n* Previous receipt of a ventricular assist device or previous heart transplantation\n* Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient\u002Fcaregiver intervention\n* Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)\n* Callahan 6-Item Cognitive Screening score ≤3",{"count":268,"type":21},400,[182],"TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no\u002Fmild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.",[272,273,27,274],"Advanced Heart Failure","Advanced Non-Colorectal Gastrointestinal Cancer","Advanced Triple Negative Breast Cancer",[276,277,278,279],"palliative care","community-based","advanced heart failure","advanced cancer","2026-02-02",{"date":194,"type":34},{"date":283,"type":21},"2026-05-01",{"date":285,"type":21},"2032-01-31",{"name":287,"class":148},"Icahn School of Medicine at Mount Sinai",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":149},"100587479","early-phase-1-inhaled-mrna-tumor-associated-antigen-dry-powder-vaccine-in-advanced-lung-cancer-and-lung-metastasis-of-solid-tumors-100587479","NCT06928922","Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.","The Phase I Clinical Study of the Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine BMD006 in Patients With Advanced Lung Cancer or Metastatic Solid Tumors in the Lungs.","Inclusion Criteria:\n\n* Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF).\n* Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible.\n* Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options.\n* Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years.\n* Presence of at least one measurable lesion as defined by RECIST V1.1\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1\n* Organ function must be adequate at screening (no need for blood transfusion, hematopoietic growth factors, human albumin, or medications for correction within 14 days prior to first treatment), specifically defined as: a) Hematology: Absolute neutrophil count ≥1.5×10\\^9\u002FL; platelet count ≥90×10\\^9\u002FL; hemoglobin ≥90 g\u002FL (9 g\u002FdL). b) Liver Function: Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); for patients with liver metastasis or a history\u002Fsuspected history of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated bilirubin, with no evidence of hemolysis or liver pathology), TBIL ≤3×ULN; for patients without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); for patients with liver metastasis, ALT or AST ≤5×ULN. c) Renal Function: Creatinine (Cr) ≤1.5×ULN or creatinine clearance (CLcr) ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula, see Attachment 3); urine dipstick test result showing urinary protein \\\u003C2+; for patients with baseline urine dipstick showing protein ≥2+, a 24-hour urine collection should be conducted, and the protein content in the 24-hour urine should be \\\u003C1 g. d) Cardiac Function: Echocardiography showing left ventricular ejection fraction (LVEF) \\>50%. e) Pulmonary Function: Shortness of breath ≤Grade 1 as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), and outdoor ambient air oxygen saturation (SpO₂) ≥92%.\n* Expected life expectancy ≥12 weeks.\n* Female patients of childbearing potential and male patients (and their female partners) must use highly effective contraception from the screening period until at least 6 months after the last dose of the study drug. Patients must not plan to conceive, donate sperm, or donate eggs during this period\n\nExclusion Criteria:\n\n* Patients with lung cancer who have concurrent other types of malignant tumors or are diagnosed with multiple primary malignancies, except for the following: completely resected basal cell carcinoma and squamous cell carcinoma of the skin, completely resected any type of carcinoma in situ.\n* Symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or those whose symptoms have been stable for ≥2 weeks after treatment of brain metastasis, they may participate in this study if they meet all the following criteria: measurable lesions in the lungs; cessation of steroid treatment 14 days prior to the first trial product dose.\n* Patients with chronic obstructive pulmonary disease (COPD), asthma, or allergies to pollen or dust.\n* Patients suspected of having active or latent tuberculosis infection, based on interferon-γ release assay results, clinical symptoms, and\u002For chest imaging findings (patients with evidence of adequately treated prior active tuberculosis infection may be enrolled after assessment by the investigator; for latent tuberculosis, patients must have completed at least 4 weeks of anti-tuberculosis treatment, with no liver function impairment \\[ALT ≤3×ULN, AST ≤3×ULN\\], and after the investigator assesses that the risk is manageable, they may be considered for continued screening or enrollment).\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, non-infectious pneumonia requiring immunosuppressive treatment such as corticosteroids.\n* Patients with active autoimmune diseases requiring therapeutic intervention.\n* History of serious bleeding disorders; or those with coagulation dysfunction (as indicated by laboratory tests or medical history) who are deemed by the investigator to be unsuitable for the trial treatment.\n* History or current diagnosis of cardiovascular disease, including any of the following: a) Recent myocardial infarction or coronary artery bypass grafting (CABG) within the past 6 months; b) Uncontrolled congestive heart failure; c) Unstable angina (within the past 6 months); d) Clinically significant (symptomatic) arrhythmias (e.g., sustained ventricular tachycardia, clinically significant second- or third-degree atrioventricular block without a pacemaker).\n* Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion\u002Fpericardial effusion; patients with effusions that do not require drainage or those whose effusions have not increased significantly after stopping drainage for 3 days may be included).\n* Severe infection requiring intravenous antibiotic treatment or hospitalization at screening, or any uncontrolled active infection within 4 weeks prior to the first dose of the trial product.\n* History of severe allergic reactions, or known allergy to any active or inactive component of BMD006 or PD-1 inhibitors.\n* Any other metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, or gastrointestinal disease that, in the investigator's opinion, may present unacceptable risks to the patient during treatment.\n* Presence of unresolved toxicity from prior anti-tumor treatments before the first dose of the study product, which has not recovered to Grade 0 or 1 (excluding alopecia) (severity assessed according to NCI CTCAE v5.0).\n* Positive test results for hepatitis B at screening \\[defined as: ① Hepatitis B surface antigen (HBsAg) positive; ② HBsAg negative but hepatitis B core antibody (HbcAb) positive (further testing through hepatitis B virus deoxyribonucleic acid \\[HBV DNA\\] is required, and patients with HBV DNA levels exceeding the normal limit for the test method must be excluded)\\], positive hepatitis C antibody (HCV Ab) \\[further testing through hepatitis C virus ribonucleic acid (HCV RNA) is required, and patients with HCV RNA levels exceeding the normal limit for the test method must be excluded\\], or positive human immunodeficiency virus antibody (HIV Ab).\n* Underwent major surgery within 4 weeks prior to the first dose of the trial product (cranial, thoracic, or abdominal surgery) or has an unresolved wound, ulcer, or fracture. Note: Thoracoscopic surgery and mediastinoscopy will not be considered major surgery. Patients who are ≥2 weeks post-surgery or who are deemed eligible by the investigator may be included in the study.\n* Previously received similar products or treatments.\n* Received other anti-tumor treatments (radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the trial product.\n* Received systemic immunosuppressive agents (e.g., systemic corticosteroids) within 3 months prior to the first dose of the trial product.\n* Received or planned to receive live or attenuated live vaccines within 3 months prior to the first dose of the trial product or during the study.\n* Pregnant or breastfeeding women.\n* Participated in any clinical drug trial (defined as being randomized and receiving trial product treatment) within 3 months or 5 half-lives (whichever is longer) prior to screening.\n* Any other condition deemed by the investigator to make the patient unsuitable for participation in the trial.","99 Years",{"count":297,"type":21},83,[24],"BMD006 is an inhaled mRNA tumor-associated antigen dry powder vaccine targeting lung cancer and solid tumors with lung metastasis, classified as an off-the-shelf anti-tumor product. The product contains two clinically validated TAA antigen combinations: for patients with solid tumors that have lung metastasis, the mRNA vaccine consists of four mRNA sequences encoding melanoma-associated tumor antigens ; for patients with primary lung cancer, the mRNA vaccine consists of six mRNA sequences encoding tumor-associated antigens of primary lung cancer .\n\nThis study is a single-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have failed standard treatments or have no standard treatment options. Additionally, the study will further explore the effect of BMD006 in combination with PD-1 or Ivonescimab Injection treatment.",[27,301],"Lung Metastasis",[303,304,305,306],"inhaled mRNA tumor-associated antigen dry powder vaccine","advanced lung cancer","solid tumors with lung metastasis","mRNA vaccine combination with PD-1 or PD-1\u002FVEGF antibody","2026-01-10",{"date":309,"type":34},"2026-01-13",{"date":311,"type":34},"2025-02-24",{"date":313,"type":21},"2028-02-24",{"name":315,"class":148},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100613016","phase-2-the-efficacy-and-safety-of-arni-on-the-outcome-of-advanced-lung-cancer-with-concurrent-hypertension-100613016","NCT07261098","The Efficacy and Safety of ARNI on the Outcome of Advanced Lung Cancer With Concurrent Hypertension","A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and Concurrent Hypertension","Inclusion Criteria:\n\n* Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.\n* Male or female aged ≥18 years and \\\u003C 80years at the time of signing the ICF.\n* Histologically or cytologically confirmed advanced lung cancer (TNM III-TNM IV) based on the 8th edition of the AJCC staging system\n* Patients were diagnosed hypertension before the diagnosis of advanced lung cancer\n* ECOG performance status score ≤ 1.\n* Adequate organ function during the screening period\n\nExclusion Criteria:\n\n* Predicted survival period less than 12 months\n* Female patients if pregnant.\n* Hypersensitivity to any component of ARNI\n* Severe renal dysfunction (eGFR\\\u003C30ml\u002Fmin\u002F1.73m2)\n* Severe liver dysfunction (Child-Pugh C)\n* Bilateral renal artery stenosis or solitary renal artery stenosis\n* Refractory hyperkalemia\n* Moderate or severe aortic stenolsis\n* Obstructive hypertrophic cardiomyopathy","80 Years",{"count":325,"type":21},200,[54],"Despite the rapid development of novel anti-cancer therapeutic agents and ensuing improved prognosis, lung cancer remains the leading cause of cancer-related death globally, of which the majority of mortality could be attributed to advanced lung cancer. Hypertension is frequently diagnosed among patients with advanced lung cancer, either a comorbidity or complication, and is associated with increased incidence of cardiac adverse events, such as heart failure, coronary artery disease, and cardiac arrhythmias, hence aggravating patients' prognosis.\n\nSacubitril\u002Fvalsartan, a combination of an angiotensin II receptor blocker and neprilysin inhibitor (ARNI), is a novel agent to treat HF and has been approved to treat hypertension in China, of which the cardio-protective effect has been widely acknowledged. Yet current knowledge remains lacking on the influence of ARNI on the prognosis of advanced lung cancer with concurrent hypertension. The present study aimed to investigate the prognostic value of ARNI in patients with advanced lung cancer and concurrent hypertension.",[27],"2025-11-21",{"date":331,"type":34},"2025-12-03",{"date":333,"type":21},"2026-01-01",{"date":335,"type":21},"2028-12-31",{"name":337,"class":148},"Shanghai Chest Hospital",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":149},"100610593","phase-1-a-study-of-mhb036c-combined-with-anti-tumor-therapies-in-patients-with-advanced-lung-cancer-100610593","NCT07229599","A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer","A Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years and≤75 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n6. For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and\u002For radical concurrent\u002Fsequential radiotherapy and chemotherapy.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate bone marrow reserve and organ function.\n9. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.\n\n   \\-\n\nExclusion Criteria:\n\n1. Small cell lung cancer (SCLC) components in the histopathology.\n2. History of ≥2 primary malignancies within 5 years prior to informed consent.\n3. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n4. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.\n5. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.\n6. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.\n7. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.\n8. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.\n9. Vaccinated within 4 weeks before dosing.\n10. Treated with systemic corticosteroids within 14 days before dosing.\n11. Severe impairment of pulmonary function; interstitial lung disease or a history of pneumonia requiring steroid treatment; previous left or right pneumonectomy.\n12. Active systemic infection requiring treatment within 7 days before dosing.\n13. Uncontrolled third-space effusion.\n14. Serious cardiovascular or cerebrovascular diseases.\n15. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n16. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n17. Known alcohol or drug dependence.\n18. Pregnant or breastfeeding women, or individuals planning to conceive. -",{"count":346,"type":21},300,[53,54],"This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.",[27],"2025-11-13",{"date":352,"type":34},"2025-11-17",{"date":354,"type":34},"2025-05-09",{"date":356,"type":21},"2030-05",{"name":358,"class":41},"Minghui Pharmaceutical (Hangzhou) Ltd",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},"100576881","multi-site-trial-of-a-brief-behavioral-intervention-for-dyspnea-in-patients-with-advanced-lung-cancer-100576881","NCT06791057","Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer","BREEZE+","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of advanced lung cancer (i.e., non-small cell lung cancer or small cell lung cancer) or mesothelioma, not being treated with curative intent\n* Self-report at least moderate dyspnea per a rating ≥4 on the validated 0-10 breathlessness item of the Edmonton Symptom Assessment Scale-Revised\n* Functioning independently per an Eastern Cooperative Oncology Group Performance Status ≤2\n* Ability to read and respond to questions in English or Spanish\n* Receiving primary cancer care at one of the participating institutions\n\nExclusion Criteria:\n\n* Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures.",{"count":367,"type":21},420,[182],"Dyspnea, or breathlessness, is one of the most common and distressing symptoms experienced by patients with advanced lung cancer. The purpose of this multi-site trial is to test the effectiveness of a dyspnea intervention (called BREEZE+) that includes three brief nurse-delivered sessions and access to a digital health app that teaches and reinforces patients' use of skills for managing and coping with this highly debilitating symptom. This study will lay the groundwork for a follow-up pragmatic implementation trial integrating BREEZE+ into usual oncology care for patients with advanced lung cancer experiencing dyspnea.",[27,371],"Dyspnea",[371,373,187,188],"Breathlessness","2025-09-23",{"date":376,"type":34},"2025-09-24",{"date":333,"type":21},{"date":379,"type":21},"2030-03-31",{"name":198,"class":148},3,{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100601428","phase-1-a-clinical-study-of-bt02-in-treating-patients-with-advanced-lung-cancer-100601428","NCT07110363","A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer","An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. Patients with pathologically confirmed locally advanced\u002Funresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced\u002Funresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .\n2. Adequate organ and hematologic function.\n3. At least 1 extracranial measurable lesion.\n4. An ECOG activity status score of 0-1.\n5. A life expectancy of ≥ 3 months.\n6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.\n7. Good compliance and willingness to follow up.\n\nExclusion Criteria:\n\n1. Patients with sensitive mutations or gene fusions related to lung cancer.\n2. Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.\n3. A history of active autoimmune disease within the past 2 years.\n4. A history of clinically significant cardiovascular disease, severe cardiac rhythm \u002Fconduction abnormalities or LVEF \\\u003C50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.\n5. A severe acute or chronic infection when enrollment.\n6. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .\n7. Unresolved \\> Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.\n8. Clinically active CNS metastases or meningeal metastases.\n9. A history of other type of malignancies.\n10. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.\n11. Poor compliance.\n12. A history of alcohol or drugs abuse.\n13. Current pregnancy or breastfeeding.\n14. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.",{"count":390,"type":21},58,[53],"The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.",[394,27,110,395],"Advanced Malignant Solid Tumor","Small Cell Lung Cancer","2025-08-05",{"date":398,"type":34},"2025-08-07",{"date":400,"type":21},"2025-08",{"date":402,"type":21},"2027-05",{"name":404,"class":41},"Biotroy Therapeutics",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":149},"100588755","phase-1-clinical-study-on-chimeric-antigen-receptor-t-lymphocyte-car-t-targeting-cea-for-the-treatment-of-cea---positive-advanced-lung-cancer-100588755","NCT06945523","Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung Cancer","Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender.\n2. Histologically or cytologically confirmed diagnosis of advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).\n3. Disease progression or intolerance following at least one line of prior therapy (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy).\n4. For patients with pleural effusion enrolled in the intrapleural infusion group, accurate assessment of pleural effusion volume and characteristics must be conducted via imaging (chest CT or X-ray) combined with cytological analysis. Cytological examination must confirm the presence of tumor cells in the pleural effusion, indicating malignant pleural effusion.\n5. Positive tumor CEA expression confirmed by immunohistochemistry (IHC) within 3 months prior to screening (defined as clear membranous staining with a positivity rate ≥10%). If IHC testing of tumor samples was performed more than 3 months prior to screening, the patient's serum CEA must be \\>10 ng\u002FmL.\n6. At least one measurable lesion according to RECIST 1.1 criteria: for non-nodal lesions, the longest diameter must be ≥10 mm; for nodal lesions, the short axis must be ≥15 mm.\n7. ECOG performance status score of 0-2.\n8. Expected survival of more than 12 weeks.\n9. No severe psychiatric disorders.\n10. Unless otherwise specified, key organ functions must meet the following requirements:\n\n    1. Hematologic: WBC \\>2.0×10⁹\u002FL, neutrophils \\>1.0×10⁹\u002FL, lymphocytes \\>0.5×10⁹\u002FL, platelets \\>50×10⁹\u002FL, hemoglobin \\>80 g\u002FL;\n    2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography, and no significant abnormalities on ECG;\n    3. Renal function: Serum creatinine ≤2.0×ULN;\n    4. Hepatic function: ALT and AST ≤3.0×ULN (≤5.0×ULN if liver metastases are present);\n    5. Total bilirubin ≤2.0×ULN;\n    6. Oxygen saturation (SpO₂) \\>92% on room air.\n11. Eligible for leukapheresis or peripheral venous blood collection and without contraindications for cell collection.\n12. Subjects must agree to use reliable and effective contraception (excluding rhythm method) from the time of informed consent until 1 year after CAR-T cell infusion.\n13. Subject or legally authorized representative must voluntarily sign the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal metastases at screening, or other evidence indicating that CNS or leptomeningeal lesions are not adequately controlled, making the patient unsuitable for enrollment as judged by the investigator.\n2. Participation in another clinical study within 1 month prior to screening.\n3. Receipt of a live attenuated vaccine within 4 weeks prior to screening.\n4. Prior antitumor therapies before screening including: chemotherapy, targeted therapy, or other investigational drugs administered within 14 days or at least 5 half-lives (whichever is shorter) before screening.\n5. Active or uncontrolled infections requiring systemic treatment.\n6. Tumor compressing the trachea or major blood vessels with high risk as assessed by the investigator.\n7. Presence of any of the following cardiac conditions:\n\n   1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmias or a history of unexplained syncope (excluding vasovagal or dehydration-related causes);\n   4. History of severe non-ischemic cardiomyopathy.\n8. Active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.\n9. History of other untreated or concurrent malignancies within the past 3 years, except for adequately treated cervical carcinoma in situ or basal cell carcinoma of the skin.\n10. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels exceeding the normal range in peripheral blood; positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels exceeding the normal range in peripheral blood; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.\n11. Pregnant or breastfeeding women.\n12. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.",{"count":413,"type":21},60,[53],"Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months.\n\nCEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types.\n\nIn previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.",[27],[418,419,27],"CEA","CAR-T","2025-05-30",{"date":422,"type":34},"2025-06-04",{"date":424,"type":34},"2025-04-28",{"date":426,"type":21},"2028-04-30",{"name":428,"class":41},"Chongqing Precision Biotech Co., Ltd",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":410,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":415,"conditions":437,"keywords":438,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":149},"100592373","phase-1-targeted-anti-cea-car-t-immunotherapy-for-advanced-lung-cancer-100592373","NCT06992583","Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age ≥18 years, regardless of gender.\n2. Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).\n3. Disease progression or intolerance after receiving standard therapies (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy):\n\n   NSCLC: Disease progression or intolerance after at least second-line standard therapy.\n\n   SCLC: Disease progression or intolerance after at least first-line standard therapy.\n4. For patients with pleural effusion assigned to the intrapleural infusion group, the pleural effusion volume and characteristics must be accurately assessed by imaging (chest CT or X-ray) combined with cytology. Malignant pleural effusion must be confirmed by the presence of tumor cells in pleural fluid cytology.\n5. Tumor CEA positivity confirmed by immunohistochemistry (IHC) within 3 months prior to screening, defined as distinct membranous staining with ≥10% positivity. If the tumor sample was assessed more than 3 months prior to screening, a serum CEA level \\>10 µg\u002FL is required.\n6. At least one measurable lesion according to RECIST 1.1 criteria:\n\n   Non-nodal lesions: longest diameter ≥10 mm. Lymph node lesions: short axis ≥15 mm.\n7. ECOG performance status score of 0 to 2 .\n8. Estimated life expectancy of more than 12 weeks.\n9. No severe psychiatric disorders.\n10. Adequate major organ function unless otherwise specified, defined as follows:\n\n    Hematology: WBC \\> 2.0 × 10⁹\u002FL; Neutrophils \\> 1.0 × 10⁹\u002FL; Lymphocytes \\> 0.5 × 10⁹\u002FL; Platelets \\> 50 × 10⁹\u002FL; Hemoglobin \\> 80 g\u002FL.\n\n    Cardiac function: LVEF ≥ 50% on echocardiogram; no significant abnormalities on ECG.\n\n    Renal function: Serum creatinine ≤ 2.0 × ULN. Hepatic function: ALT and AST ≤ 3.0 × ULN (≤ 5.0 × ULN if there is hepatic tumor infiltration).\n\n    Total bilirubin ≤ 2.0 × ULN. Peripheral oxygen saturation \\>92% in room air.\n11. Eligible for leukapheresis or venous blood collection, with no contraindications to cell collection.\n12. Willing to use reliable and effective contraception methods (excluding rhythm method) from informed consent signing until one year after CAR-T cell infusion.\n13. Participant or legally authorized representative has voluntarily signed the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.\n\nExclusion Criteria:\n\n\\-\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Clinically symptomatic central nervous system (CNS) metastasis or meningeal metastasis at screening, or other evidence suggesting the presence of uncontrolled CNS or meningeal metastasis, as judged by the investigator.\n2. Participation in any other clinical trial within 1 month prior to screening.\n3. Vaccination with a live attenuated vaccine within 4 weeks prior to screening.\n4. Receipt of the following anti-tumor treatments within 4 weeks prior to screening: chemotherapy, targeted therapy, or any experimental drug treatment within 14 days or at least 5 half-lives (whichever is shorter).\n5. Active infection requiring systemic treatment or any uncontrolled infection.\n6. Tumor compression of the trachea or major blood vessels, as determined by the investigator to carry a high risk.\n7. History of the following cardiac conditions:\n\n   NYHA Class III or IV congestive heart failure. Myocardial infarction or coronary artery bypass graft (CABG) surgery within 6 months prior to enrollment.\n\n   Clinically significant ventricular arrhythmias or a history of unexplained syncope (except due to vasovagal or dehydration-related causes).\n\n   History of severe non-ischemic cardiomyopathy.\n8. Active autoimmune disease or any condition requiring long-term immunosuppressive therapy.\n9. History of any other untreated malignancy within the past 3 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.\n10. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above normal range; positive for hepatitis C antibody with peripheral blood HCV RNA levels above normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.\n11. Pregnancy or breastfeeding women.\n12. Any other condition that the investigator deems unsuitable for participation in the study.",{"count":413,"type":21},[53],[27],[418,419,27],"2025-05-19",{"date":441,"type":34},"2025-05-28",{"date":443,"type":34},"2025-05-08",{"date":426,"type":21},{"name":428,"class":41},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":410,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":415,"conditions":454,"keywords":455,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":149},"100585496","phase-1-anti-cea-car-t-for-advanced-cea-positive-lung-carcinoma-100585496","NCT06903117","Anti-CEA CAR-T for Advanced CEA-Positive Lung Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;\n3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug\u002FL.\n5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.\n6. ECOG score 0-2 points ;\n7. The expected survival time is more than 12 weeks;\n8. no serious mental disorders;\n9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:\n\n   1. Blood routine: Neutrophils\\>1.0×109\u002FL, platelet\\>75×109\u002FL, hemoglobin \\> 80g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);\n   5. Total bilirubin ≤2.0×ULN;\n   6. Blood oxygen saturation in non-oxygen state\\>92%.\n10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;\n12. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms at the time of screening, or with other evidence that the central nervous system metastasis or meningeal metastasis was not controlled, and the investigators judged that they were not suitable for inclusion;\n2. Participating in other clinical studies within 1 month before screening;\n3. Received live attenuated vaccine within 4 weeks prior to screening;\n4. have received any of the following anti-tumor therapies prior to screening: chemotherapy, targeted therapy, or other investigational agents within 14 days or at least 5 half-lives, whichever is shorter;\n5. There is an active infection or uncontrollable infection that requires systemic treatment;\n6. The tumor compresses the trachea or important large blood vessels, and the risk is greater as assessed by researchers;\n7. There is a large number of uncontrollable fluid accumulation in the serous cavity;\n8. Toxicity of previous antitumor therapy has not improved to baseline level or ≤ grade 1, except for alopecia or peripheral neuropathy;\n9. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n10. Patients with active autoimmune diseases, or other patients requiring long-term immunosuppressive therapy;\n11. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;\n12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive;\n13. Women who are pregnant or breastfeeding;\n14. Circumstances deemed unsuitable for participation in the study by other researchers.",{"count":413,"type":21},[53],[27],[418,419],"2025-03-30",{"date":458,"type":34},"2025-04-03",{"date":460,"type":34},"2025-03-24",{"date":462,"type":21},"2028-03-31",{"name":428,"class":41},{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":410,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":415,"conditions":473,"keywords":474,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":149},"100575120","phase-1-a-clinical-trial-of-cea-targeting-car-t-for-cea-positive-advanced-lung-cancer-100575120","NCT06768151","A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;\n3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug\u002FL.\n5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.\n6. ECOG score 0-2 points ;\n7. The expected survival time is more than 12 weeks;\n8. no serious mental disorders;\n9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:\n\n   1. Blood routine: Neutrophils \\> 1.0×109\u002FL, platelet \\> 75×109\u002FL, hemoglobin \\> 80g\u002FL;\n   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n   3. Renal function: serum creatinine ≤2.0×ULN;\n   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);\n   5. Total bilirubin ≤2.0×ULN;\n   6. Blood oxygen saturation in non-oxygen state \\> 92%.\n10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;\n11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;\n12. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms at the time of screening, or with other evidence that the central nervous system metastasis or meningeal metastasis was not controlled, and the investigators judged that they were not suitable for inclusion;\n2. Participating in other clinical studies within 1 month before screening;\n3. Received live attenuated vaccine within 4 weeks prior to screening;\n4. have received any of the following anti-tumor therapies prior to screening: chemotherapy, targeted therapy, or other investigational agents within 14 days or at least 5 half-lives, whichever is shorter;\n5. There is an active infection or uncontrollable infection that requires systemic treatment;\n6. The tumor compresses the trachea or important large blood vessels, and the risk is greater as assessed by researchers;\n7. There is a large number of uncontrollable fluid accumulation in the serous cavity;\n8. Toxicity of previous antitumor therapy has not improved to baseline level or ≤ grade 1, except for alopecia or peripheral neuropathy;\n9. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n10. Patients with active autoimmune diseases, or other patients requiring long-term immunosuppressive therapy;\n11. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;\n12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive;\n13. Women who are pregnant or breastfeeding;\n14. Circumstances deemed unsuitable for participation in the study by other researchers.",{"count":471,"type":21},48,[53],[27],[418,419],"2025-01-06",{"date":477,"type":34},"2025-01-10",{"date":479,"type":34},"2024-12-12",{"date":481,"type":21},"2027-12-31",{"name":428,"class":41},{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":491,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":149},"100530206","a-real-world-study-of-treatment-patterns-and-effectiveness-in-met-mutation-positive-advanced-lung-cancer-100530206","NCT06183762","A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer","Real-World Treatment Patterns and Effectiveness of Targeted and Systemic Therapy in Patients With Advanced Lung Cancer Carrying MET Mutation-Positive","Inclusion Criteria:\n\n1. Patients must be ≥18 years of age.\n2. Provision of fully informed consent prior to any study specific procedures.\n3. Histologically or cytologically confirmed, unresectable stage IIIB\u002FIIIC or stage IV NSCLC.\n4. Genetic variants of tumor tissue detected by NGS.\n\nExclusion Criteria:\n\nNone.",{"count":325,"type":21},"OBSERVATIONAL","This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).",[27],"2024-09-17",{"date":496,"type":34},"2024-09-19",{"date":498,"type":34},"2020-01-01",{"date":500,"type":21},"2025-06-30",{"name":502,"class":148},"Hunan Province Tumor Hospital",{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":149},"100551134","phase-1-trametinib-plus-anlotinib-combined-with-tislelizumab-in-kras-mutant-nsclc-100551134","NCT06456138","Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC","Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant Advanced Non-small Cell Lung Cancer Patients: a Multi-center, Open-label, Phase 1\u002F2 Study","Inclusion Criteria:\n\n1. According to the 8th edition of the AJCC\u002FUICC TNM staging system for NSCLC, patients with locally advanced (stage III B\u002FIII C), metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.\n2. KRAS mutation positive detected by ARMS or NGS;\n3. Have been treated with 1st line of standard therapy and experienced disease progression;\n4. Patients who were assessed as CR, PR, or SD (reduction) after being treated with 2 cycles of anlotinib and trametinib.\n5. No active brain metastases;\n6. Age ≥18 years and ≤75 years;\n7. ECOG PS score: 0 to 2;\n8. Palliative radiotherapy must be completed 7 days before the first dose of study drug is administered;\n9. The main organs function is normal, that is, the following criteria met:\n10. Good hematopoietic function, defined as absolute neutrophil count ≥1.5×10\\^9 \u002FL, platelet count≥100 ×10\\^9 \u002FL, hemoglobin ≥90g\u002FL \\[no blood transfusion or no erythropoietin (EPO) dependence within 7 days before enrollment\\]\n11. Biochemical test results should meet the following criteria: BIL \\\u003C 1.25 times the upper limit of normal value (ULN); ALT and AST \\\u003C 2.5 × ULN; in case of liver metastases, ALT and AST \\\u003C 5 × ULN; Cr ≤1.5×ULN or creatinine clearance (CCr) ≥60ml\u002Fmin; Coagulation function is good, INR and PT ≤1.5 times ULN; if the subject is receiving anticoagulant treatment, PT should be within the prescribed range of use of anticoagulant drugs;\n12. Women of child-bearing age should agree to take contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; non-breast-feeding patients whose serum or urinary pregnancy test should be negative; male patients should agree to take contraceptive measures during the study and within 6 months after the study.\n13. Patients are voluntarily enrolled into the study, sign the informed consent form and have good compliance.\n\nExclusion Criteria:\n\n1. Small cell lung cancer (including mixed small cell and non-small cell lung cancer);\n2. Patients who have received previous treatment ≥ 4th lines of standard therapies.;\n3. There are obvious bleeding symptoms or active autoimmune disease;\n4. Patients with other driver mutation.\n5. Patients with many factors affecting oral medication, such as dysphagia, gastrointestinal resection, chronic diarrhea and intestinal obstruction;\n6. Patients who are known to have active brain metastases, spinal cord compression, carcinomatous meningitis, or brain or leptomeningeal disease diagnosed by CT or MRI at the time of screening;\n7. Patients with severe and \u002F or uncontrolled diseases, such as:\n8. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n9. Active or uncontrolled serious infection;\n10. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n11. Not completely controlled eye inflammation or eye infection, or any condition that may lead to the above-mentioned ocular diseases\n12. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n13. Routine urine test result indicates that urine protein ≥++, and 24-hour urine protein quantitation is confirmed to be \\> 1.0 g;\n14. Active tuberculosis, etc.;\n15. Uncontrolled hypercalcemia (\\> 1.5 mmol\u002FL calcium ion or calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued diphosphate therapy;\n16. Long-term unhealed wounds or fractures;\n17. Patients who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders;\n18. Patients who are known to have severe allergies (≥ grade 3) to active ingredients and any excipients of study drugs;\n19. Patients who have other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.) at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients completing the study.\n20. The subjects or their sexual partners cannot or refuse to take effective contraceptive measures during the clinical trial.\n21. Pregnant or breast-feeding women.\n22. Patients who are allergic to any medicine or any ingredient; the patients with a history of treatments involving MEK inhibitors (trametinib, selumetinib, etc.) and RTKs inhibitors (anlotinib, sorafenib, apatinib, cabozantinib, etc.) were considered ineligible.\n23. Patients in other situations who are evaluated by the investigator to be ineligible to be enrolled.",{"count":413,"type":21},[53,54],"Lung cancer is the most common cause of cancer-related death worldwide. Approximately 85% to 90% of lung cancer cases are non-small cell lung cancer (NSCLC), of which KRAS is one of the most common driver genes, occurring in 25-30% of lung adenocarcinomas and 3-5% of squamous cell carcinomas. KRAS-mutant NSCLC had been considered undruggable in past decades. This research sought to address a significant challenge in treating NSCLC with KRAS mutations, which are notoriously difficult to target effectively. Here, we proposal that the combined use of anlotinib and trametinib combined with tislelizumab may form an effective strategy for the treatment of KRAS-mutant NSCLC patients.",[514,27,515],"KRAS Mutation-Related Tumors","Refractory Tumor",[517,518,519,520],"KRAS-mutant NSCLC","Trametinib","Anlotinib","Tislelizumab","2024-06-10",{"date":523,"type":34},"2024-06-13",{"date":525,"type":21},"2024-07-01",{"date":335,"type":21},{"name":337,"class":148}]