[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-non-small-cell-lung-cancer":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,70,93,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100592696","phase-1-a-platform-study-in-non-small-cell-lung-cancer-nsclc-100592696",false,"NCT06996782","A Platform Study in Non-Small Cell Lung Cancer (NSCLC)","A Phase Ib\u002FII Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer","ALTAIR","Inclusion Criteria:\n\n* Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.\n* Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.\n* Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.\n* Minimum life expectancy of 12 weeks in the opinion of the investigator.\n* Adequate organ and marrow function.\n* Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate organ and marrow function.\n\nInclusion Criteria for Sub Study 2:\n\n* Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report).\n* Adequate coagulation and urinalysis.\n* Minimum body weight of 30 kg.\n\nExclusion Criteria:\n\n* Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of care.\n* Presence of small cell and neuroendocrine histology components.\n* Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease\u002Fpneumonitis (of any grade); unstable and\u002For symptomatic venous thromboembolism, serious chronic gastrointestinal conditions associated with diarrhoea, active non-infectious skin disease or substance abuse.\n* Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.\n* Has an active autoimmune disease that has required systemic treatment in the past 5 years.\n* History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention or presence of small cell and neuroendocrine histology components.\n* Persistent toxicities (common terminology criteria for adverse events \\[CTCAE\\] ≥ Grade 2) caused by previous anti-cancer therapy, excluding alopecia.\n* Spinal cord compression or symptomatic brain metastases.\n* Treatment with any other anti-cancer agents or immunosuppressive medication.\n* Palliative radiotherapy with a limited field of radiation within 2 weeks or with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.\n\nExclusion Criteria for Sub Study 2:\n\n* Known active hepatitis A.\n* Acute hepatitis B infection (anti-hepatitis B core antibody \\[HBc\\] immunoglobulin M \\[IgM\\] positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU\u002FmL.\n* Active hepatitis C infection (anti-HCV positive with HCV RNA detectable) or anti- HCV positive with HCV RNA undetectable for less than 12 weeks following treatment for HCV.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Evidence of Grade ≥ 1 central nervous system (CNS) haemorrhage.\n* Uncontrolled arterial hypertension ≥ 150 mm Hg (systolic) and\u002For ≥ 100 mm Hg (diastolic).\n* Has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or major airway invasion by cancer or intra-tumour cavitation.\n* Has experienced any arterial thrombotic event, a Grade ≥ 3 bleeding event or has gross haemoptysis.\n* Has significant bleeding disorders, serious or nonhealing wound, ulcer or clinically relevant congestive heart failure.\n* Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.\n* Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.\n* Prior systemic therapy received for advanced or mNSCLC.\n* Prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif domains (TIGIT) therapy or immune-oncology agent such as anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.\n* Chronic therapy with antiplatelet agents.\n* Prior exposure to anti-vascular endothelial growth factor (VEGF) therapy.\n* Medical contraindication to protocol-specified platinum doublet regimens or ramucirumab.\n* Known allergy or hypersensitivity to rilvegostomig or any of the excipients of rilvegostomig, cisplatin, carboplatin, paclitaxel or nab-paclitaxel or pemetrexed or ramucirumab.","ALL","18 Years",{"count":20,"type":21},152,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.",[28],"Advanced or Metastatic Non-small Cell Lung Cancer",[30,31,32,33],"Checkpoint inhibitor (CPI)","Platinum-based chemotherapy","T-cell immunoreceptor with lg and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT)","Programmed death-ligand 1 (PD-L1)","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2025-11-24",{"date":42,"type":21},"2029-02-23",{"name":44,"class":45},"AstraZeneca","INDUSTRY",103,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100555435","phase-1-a-trial-of-shr-a2102-with-adebrelimab-with-or-without-other-antitumor-therapy-in-advanced-or-metastatic-non-small-cell-lung-cancer-100555435","NCT06512051","A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","A Phase IB \u002FII, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.\n2. The age of signing the informed consent is 18 -70 years, regardless of gender.\n3. Provide archived or fresh tumor tissue for vendor test.\n4. At least one measurable lesion according to RECIST v1.1 criteria.\n5. Patients with locally advanced or metastatic non-small cell lung cancer who have been confirmed by histological or cytological examination to be inoperable and unable to undergo radical radiotherapy or chemotherapy.\n6. The ECOG score is 0 or 1.\n7. Expected survival ≥12 weeks.\n8. Good level of organ function.\n9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Active or symptomatic brain metastases.\n2. With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.\n3. Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion.\n4. Patients with uncontrolled tumor-related pain .\n5. Have antitumor therapy was received 4 weeks before the start of the study.\n6. Perform non-chest radiation therapy with \\>30 Gy within 28 days before dosing, chest radiation therapy with \\>30 Gy within 24 weeks before first dosing, and radiation therapy with ≤30 Gy within 14 days before first dosing.\n7. Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is longer.\n8. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period.\n9. Toxicity and\u002For complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria\n10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study.\n11. Subjects with a prior history of interstitial pneumonia\u002Fnon-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia\u002Fnon-infectious pneumonia.\n12. The presence of any active, known or suspected autoimmune disease.\n13. Subjects with severe cardiovascular and cerebrovascular diseases.\n14. Subjects who had a severe infection within 28 days prior to the first dose\n15. Active hepatitis B or active hepatitis C.\n16. Patients with active pulmonary tuberculosis within 1 year prior to enrolment.\n17. Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication\n18. History of immune deficiency\n19. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；\n20. Female subjects who are pregnant or plan to become pregnant during the study period.\n21. Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.\n22. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.\n23. Having a bleeding tendency, a high risk of bleeding, coagulation dysfunction or thrombosis tendency (for patients using bevacizumab).\n24. Poorly controlled hypertension (with regular antihypertensive treatment, systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), as well as previous occurrence of hypertensive crisis or hypertensive encephalopathy (in patients using bevacizumab).\n25. Within 6 months prior to the first administration of the medication, had a major vascular disease (for patients using bevacizumab).\n26. If within 7 days prior to the first administration of the drug, the patient had used the full dose of oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes, prophylactic anticoagulation treatment for the open intravenous infusion system is permitted, and prophylactic use of low-molecular-weight heparin (for patients using bevacizumab) is also allowed.\n27. Within 7 days prior to the first administration, the patient has used or needs to use aspirin, dipyridamole, ticlopidine, clopidogrel, cilostazol or other drugs that inhibit platelet function (for patients using bevacizumab).\n28. Having severe, non-healed wounds, active ulcers or untreated fractures (for patients using bevacizumab).\n29. Within 6 months prior to the first administration of the drug, there had been a history of gastrointestinal perforation. During the screening process, clinical symptoms or signs indicated the presence of intestinal obstruction (for patients using bevacizumab).\n30. CT\u002FMRI indicated that the tumor surrounded or invaded major blood vessels (for patients who received bevacizumab treatment).\n31. Subjects who have previously received systemic treatment with anti-angiogenic drugs such as VEGF\u002FVEGFR inhibitors, including but not limited to bevacizumab, recombinant human endostatin, anlotinib, etc. (patients who used bevacizumab).","70 Years",{"count":56,"type":21},248,[24,25],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.\n\nTo explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer",[28],"2025-12-16",{"date":62,"type":38},"2025-12-23",{"date":64,"type":38},"2024-07-30",{"date":66,"type":21},"2026-10",{"name":68,"class":45},"Shanghai Hengrui Pharmaceutical Co., Ltd.",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":69},"100606088","phase-3-phase-iii-study-of-shr-8068-combined-with-adebrelimab-and-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-in-the-treatment-of-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100606088","NCT07170995","Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer","A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntary participation and written informed consent.\n2. 18-75 years old, no gender limitation.\n3. Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.\n4. Confirmed tumor PD-L1 status prior to randomization.\n5. Eastern Cooperative Oncology Group (ECOG) score: 0-1\n6. With a life expectancy ≥ 3 months.\n7. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;\n2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;\n3. Previous or co-existing malignancies；\n4. Have Active or prior documented autoimmune or inflammatory disorders;\n5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;\n6. Have an active or past medical history of interstitial lung disease (ILD)\u002Fpneumonitis, including drug-induced or radiation ILD\u002Fpneumonitis.","75 Years",{"count":79,"type":21},460,[81],"PHASE3","This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.",[28],"2025-11-14",{"date":86,"type":38},"2025-11-18",{"date":88,"type":38},"2025-10-22",{"date":90,"type":21},"2030-12",{"name":92,"class":45},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":69},"100560766","phase-1-a-clinical-trial-to-evaluate-effect-of-iap0971-in-patients-with-advanced-malignant-tumors-100560766","NCT06581419","A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","A Phase I\u002FII Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors","Inclusion Criteria:\n\n1. Age of 18-75 years old (including cut-off value), regardless of gender.\n2. Phase I only: patients with histologically confirmed advanced or metastatic malignant solid tumors who have failed to respond to standard treatment, who have no standard treatment options, who are not currently applicable to standard treatment, or who have been assessed by the investigator to benefit from this treatment.\n3. Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and definitive concurrent chemoradiotherapy. Note: For patients with locally advanced stage (stage IIIB\u002FIIIC) who cannot accept radical concurrent\u002Fsequential chemoradiotherapy, they need to be evaluated by relevant professional physicians and confirmed by written records.\n4. Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant\u002Fneoadjuvant chemotherapy or definitive concurrent or sequential chemoradiotherapy for locally advanced disease and disease progression ≥6 months after the last treatment).\n5. Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) by immunohistochemistry.\n6. have at least one measurable lesion according to RECIST 1.1 criteria (tumor lesion located in the previous radiotherapy area or other locoregional treatment site, generally not considered a measurable lesion unless the lesion has clearly progressed or persists beyond three months of radiotherapy).\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n8. predicted survival time ≥3 months.\n9. with adequate organ function:\n\n   ① Blood system (no blood transfusion or hematopoietic stimulation therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (HGB) ≥90 g\u002FL; ② Liver function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), except Gilbert's syndrome Out of; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, and patients with liver metastasis or liver cancer need AST and ALT≤5.0 times ULN and total bilirubin ≤3.0 times ULN;\n\n   ② Renal function: serum creatinine (Cr) ≤1.5 times ULN; If creatinine \\> 1.5 times ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) was required.\n\n   ③ Coagulation function: prothrombin international normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN, patients with liver metastasis or liver cancer need INR and APTT≤2.5 times ULN.\n10. Eligible patients (men and women) of childbearing potential must consent to use a reliable method of contraception (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 6 months after the last dose; Female patients of reproductive age had to have a negative blood pregnancy test within 7 days before the first use of the study drug.\n11. Subjects must give informed consent for this study and voluntarily provide written informed consent before the trial.\n\nExclusion Criteria:\n\n1. Phase II only: small cell lung cancer or sarcomatoid lesion confirmed by histopathology.\n2. Phase II only: previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 \u002FPD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action.\n3. Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of study drug; The following drugs were excluded according to the following criteria:\n\n   ① Treatment with a small-molecule tyrosine kinase inhibitor within 2 weeks before the first dose;\n\n   ② Palliative local treatment for non-target lesions within 2 weeks before the first dose; Patients received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, not including IL-11) within 2 weeks before the first dose;\n\n   ③ received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.\n4. received other investigational drugs or treatments within 4 weeks before the study drug.\n5. received systemic glucocorticoids (prednisone \\> 10 mg\u002F day or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug; The use of topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy).\n6. the adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 or the relevant requirements of the inclusion criteria (except for toxicities without safety risks judged by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy).\n7. major surgical procedures (excluding needle biopsies) within 4 weeks before the first dose of study drug, major trauma, or the need for elective surgery during the trial.\n8. prior allogeneic hematopoietic stem-cell transplantation or organ transplantation.\n9. clinically symptomatic parenchymal or meningeal metastases.\n10. have active infection and currently require intravenous anti-infective therapy.\n11. have a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibodies.\n12. active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).\n13. received any live vaccine within 4 weeks before the first dose of study drug.\n14. known hypersensitivity to any antibody-based drug (NCI CTCAE grade 5.0 ≥3) or to the study drug, active ingredient, or inactive excipients of a PD-1\u002FPD-L1 inhibitor.\n15. with severe and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.); Or other moderate-to-severe lung diseases that severely affect respiratory function that may interfere with the detection or management of drug-related pulmonary toxicity.\n16. have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    ① Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.\n\n    ② Mean QT interval corrected with Fridericia's method (QTcF) \\> 470 ms;\n\n    ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first dose; ④ patients with New York Heart Association (NYHA) functional class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or structural heart disease with high risk as judged by other investigators; And 5) clinically uncontrolled hypertension.\n17. have an active or previous autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with the possibility of recurrence, except clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years) that does not require systemic treatment.\"\n18. had other malignancies within 5 years before study administration, except for malignancies that could be expected to be cured with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).\n19. have clinically uncontrollable effusion in the third space, which was judged by the investigator to be not suitable for enrollment.\n20. known alcohol or drug dependence.\n21. with mental disorders or poor adherence.\n22. pregnant or lactating women.\n23. The participant was deemed by the investigator to have a history of other serious systemic diseases or to be ineligible for the study for other reasons.",{"count":101,"type":21},78,[24,25],"Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors.\n\nPhase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.",[105,28],"Advanced Malignant Neoplasm","2025-01-13",{"date":108,"type":38},"2025-01-15",{"date":110,"type":38},"2024-12-31",{"date":112,"type":21},"2029-08-01",{"name":114,"class":45},"SUNHO（China）BioPharmaceutical CO., Ltd.",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":69},"100567911","phase-3-furmonertinib-160mg-as-first-line-treatment-in-locally-advanced-or-metastatic-nsclc-with-egfr-classical-mutations-100567911","NCT06674343","Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations","The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study","Inclusion Criteria:\n\n* ≥ 18 years old, Male or Female\n* Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;\n* Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)\n* Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy\n* Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy\n* Adequate organ function as shown in the laboratory test, including: (1) ANC \\>= 1.5 x 10\\^9\u002FL; PLT \\>= 100 x 10\\^9\u002FL; HGB \\>= 90 g\u002FL; (2) TBIL \\\u003C= 1.5 times ULN, AST and ALT \\\u003C= 2.5 times ULN (with liver metastasis, TBIL \\\u003C= 3 times ULN, AST and ALT \\\u003C= 5 times ULN); (3) CrCL \\>= 50 mL\u002Fmin (according to Cockcroft-Gault formula);\n* ECOG PS 0-1, and there was no obvious disease deterioration within 2 weeks prior to screening\n* Life expectancy \\> 12 weeks after the first dose of investigational product\n* Female of childbearing age are not pregnant and have no pregnancy plan. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation\n* Being able to understand and voluntarily participate in the study, and sign the informed consent form.\n\nExclusion Criteria:\n\n* NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test\n* Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRAC mutation, etc.);\n* Expected to receive other anti-tumor therapy other than the investigational product during the study\n* Having received the following therapies: (1) Having been irradiated for \\> 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;\n* Concurrent spinal cord compression or symptomatic brain metastasis\n* The toxicity caused by previous anti-tumor therapy has not recovered to \\\u003C= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) or the level specified in the inclusion\u002Fexclusion criteria;\n* Unstable pleural effusion or peritoneal effusion with obvious symptoms; those with stable clinical symptoms for at least 14 days after drainage of pleural effusion or ascites will be eligible\n* Having a history of other malignant tumor, or other concurrent malignant tumors (except those that have undergone radical operation and have no recurrence within 5 years post operation, e.g. cervical carcinoma in situ, basal cell carcinoma of skin and papillary thyroid carcinoma)\n* Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease\n* Having severe or uncontrolled systemic disease requiring treatment that is considered by investigators as ineligible for the study, including hypertension, diabetes, chronic heart failure (NYHA Functional Classification III-IV), unstable angina pectoris, myocardial infarction within one year, active hemorrhagic disease, etc.\n* QTc \\> 470 ms on ECG at resting state\n* Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval\n* Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product\n* Infectious disease requiring intravenous medication\n* Known history of mental disease or drug abuse, and currently having an attack or still taking drugs\n* Known or suspected allergy to Furmonertinib or other components of its preparation\n* Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study\n* Poor compliance, inability to comply with the study procedures, restriction or requirements\n* Other conditions that are considered by investigators as unsuitable to participate in this study.",{"count":123,"type":21},144,[81],"To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).",[28],[128,129],"advanced or metastatic non-small cell lung cancer","EGFR mutation","2024-11-03",{"date":132,"type":38},"2024-11-05",{"date":134,"type":38},"2024-07-15",{"date":136,"type":21},"2028-12-31",{"name":138,"class":139},"Peking Union Medical College Hospital","OTHER","Advanced or Metastatic Non-Small Cell Lung Cancer"]