[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong Association of Clinical Trials\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":375},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,40,63,90,114,136,162,192,213,236,261,282,303,328,353],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100643047","rgl-270--ici-in-advanced-nsclc-100643047",false,"NCT07652125","RGL-270 + ICI in Advanced NSCLC","An Exploratory Study of RGL-270 in Combination With PD-1\u002FPD-L1 Inhibitors in Patients With Unresectable Locally Advanced or Recurrent\u002FMetastatic Non-Small Cell Lung Cancer","1. Subjects capable of understanding\u002Fcompliance with study procedures and voluntarily signing informed consent.\n2. Age ≥18, any gender.\n3. Histologically\u002Fcytologically confirmed NSCLC.\n\n5.ECOG performance status 0 or 1.\n\n6.Life expectancy ≥6 months.\n\n7\\. Subject must have at least one measurable tumor lesion by RECIST 1.1 criteria at baseline prior to first-line treatment.\n\nNote: Previously irradiated lesions not eligible as target lesions unless documented progression post-radiation.\n\n8\\. Subjects with asymptomatic central nervous system (CNS) metastases (excluding meningeal or cerebrospinal membrane metastases) are allowed. For symptomatic CNS metastases, the condition must be stable after local treatment and no steroid or anticonvulsant treatment is required at least 7 days before enrollment (antiepileptic drugs are allowed).\n\n9.Willing to provide sufficient fresh tumor tissue or archival specimens for genomic profiling and neoantigen analysis (fresh tissue preferred).\n\n10.Willing to provide blood samples for immunogenicity\u002Fbiomarker assessments at all timepoints. Pre-biopsy samples require no transfusion\u002Fblood products\u002FG-CSF within 10 days.\n\n11.Adequate organ function (no blood products\u002Fgrowth factors within 10 days prior to testing):\n\nHematology:\n\nANC ≥1.5×10⁹\u002FL, LYM ≥0.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL\n\nBiochemistry:\n\nTBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN, ALB ≥30g\u002FL, Scr ≤1.5×ULN\n\nCoagulation:\n\nINR ≤1.5, APTT ≤1.5×ULN\n\nCardiac:\n\nLVEF ≥50%\n\nECG:\n\nQTcF \\\u003C470 ms (Fridericia's correction: QTcF=QT\u002FRR⁰·³³)\n\n12.Women of childbearing potential (WOCBP): Negative pregnancy test within 7 days prior to treatment; non-lactating.\n\n13.Women and male subjects with fertile partners must use contraception from consent until 90 days post-last treatment (see Appendix V).\n\nReal-World Observational Cohort Addendum:\n\nExempt from tissue provision (Criterion 9) and immunogenicity blood sampling (Criterion 10). All other inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed small cell lung cancer (SCLC), mixed tumors with SCLC components, neuroendocrine tumors with large cell components, or sarcomatoid carcinoma.\n2. Actionable driver mutations (e.g., EGFR\u002FALK) where targeted therapy is accessible per investigator assessment, except for patients refusing targeted treatment.\n3. Prior radiotherapy within 5 years or history of immunotherapy\u002Fcancer vaccines (including but not limited to TILs, CAR-T, TCR-T, therapeutic cancer vaccines).\n4. Live vaccines administered ≤28 days pre-screening or planned during study\u002Fwithin 90 days post-treatment (inactivated vaccines permitted).\n5. Investigator-assessed contraindications for immunotherapy.\n6. Active autoimmune diseases (exclusion: hypothyroidism from autoimmune thyroiditis requiring hormone replacement only).\n7. Evidence of active tuberculosis within 1 year pre-screening, regardless of treatment.\n8. History of interstitial lung disease (ILD), suspected active ILD on screening CT, or idiopathic pulmonary fibrosis\u002Forganizing pneumonia (e.g., BOOP\u002Fcryptogenic OP).\n9. Severe active infection requiring IV antibiotics\u002Fantifungals\u002Fantivirals ≤28 days pre-screening or during screening.\n10. Clinically uncontrolled effusions requiring drainage ≤14 days pre-screening (pleural\u002Fperitoneal\u002Fpericardial).\n11. Hypersensitivity to study drug excipients or severe vaccine allergy history.\n12. Other malignancies within 5 years (exceptions: cured cervical CIS, basal\u002Fsquamous skin cancer, localized prostate cancer post-radical therapy, DCIS, papillary thyroid cancer).\n13. Allogeneic organ or hematopoietic stem cell transplantation.\n14. Congenital\u002Facquired immunodeficiency (e.g., DiGeorge syndrome, T-\u002FB-cell deficiencies, Wiskott-Aldrich, ataxia-telangiectasia, CVID) or HIV infection.\n15. Active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] at screening AND HBV DNA ≥500 IU\u002FmL or above the upper limit of normal \\[ULN\\] at the local institution), OR active hepatitis C (defined as positive hepatitis C antibody \\[HCV-Ab\\] at screening AND detectable HCV-RNA).\n16. Uncontrolled or significant cardiovascular disease, including:\n\n    Symptomatic congestive heart failure (NYHA Class III or IV) Myocardial infarction within 6 months prior to screening Unstable angina within 1 month prior to screening Clinically significant arrhythmias requiring therapeutic intervention Refractory hypertension despite adequate treatment (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg)\n17. Any other condition deemed by the investigator to potentially compromise trial conduct or outcome interpretation, including but not limited to:\n\n    Anticipated poor compliance with study procedures Comorbidities posing unacceptable safety risks Insufficient neoantigen burden for vaccine production (based on tumor sequencing analysis) Vaccine manufacturing failure\n18. Subjects who experienced severe irAE during the run-in treatment period resulting in permanent discontinuation of PD-1\u002FPD-L1 inhibitors.\n19. If a subject experiences comprehensive disease progression during the introduction treatment but only has clinical deterioration, or if the intracranial lesion stabilizes after local treatment and the investigator assesses that medication can continue, they are allowed to continue participating in the study.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1\u002FPD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1\u002FPD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.",[26],"NSCLC","RECRUITING","2026-06-26",{"date":30,"type":31},"2026-06-30","ACTUAL",{"date":33,"type":31},"2025-10-25",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"Guangdong Association of Clinical Trials","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100621799","phase-2-a-ctdna-guided-phase-ii-trial-of-osimertinib-in-combination-with-sacituzumab-tirumotecan-in-egfr-mutated-advanced-nsclc-patients-with-positive-ctdna-after-lead-in-osimertinib-monotherapy-100621799","NCT07375316","A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy","A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy","Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the Informed Consent Form (ICF), regardless of gender;\n2. Histologically or cytologically confirmed locally advanced (stage IIIB\u002FIIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and\u002For radical radiotherapy (regardless of concurrent\u002Fsequential chemotherapy) (according to TNM staging of lung cancer published by the Union for International Cancer Control and American Joint Committee on Cancer (UICC\u002FAJCC), 8th edition);\n3. Presence of sensitizing EGFR mutation (exon 19 deletion and\u002For L858R);\n4. Completion of 3\\~5-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1, and willing to undergo ctDNA testing (patients with positive ctDNA test results will be enrolled in Cohort 1; patients with negative ctDNA test results will be enrolled in observational Cohort 2);\n5. ≥1 measurable target lesion per RECIST v1.1;\n6. ECOG Performance Status score of 0 or 1 within 7 days before enrollment;\n7. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy within 2 weeks prior to the first dose), defined as follows:\n\n   1. Hematology: neutrophil count (NEUT) ≥ 1.5×109\u002FL; platelet (PLT) ≥ 100×109\u002FL; hemoglobin(Hb) ≥ 90g\u002FL;\n   2. Liver function: AST and ALT ≤ 2.5× ULN (if liver metastases are present, ≤5 × ULN); total bilirubin (TBIL) ≤ 1.5×ULN (if liver metastases are present, ≤3 × ULN); serum albumin ≥30g\u002FL;\n   3. Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula);\n   4. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5× ULN;\n8. Use of effective medical contraception during the study treatment period and for 6 months after the end of dosing for female subjects of childbearing potential and male subjects with partners of childbearing potential;\n9. Willingness to participate in the study, sign the ICF, and comply with the protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n1. For NSCLC, histologically or cytologically confirmed squamous cell carcinoma component or presence of coexisting small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma component;\n2. Known presence of meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, and active brain metastases. Patients with asymptomatic, focal leptomeningeal metastases on contrast-enhanced MRI may be eligible if, in the investigator's opinion, no local therapy or dehydration\u002Fsymptomatic treatment is required;\n3. Prior treatment with systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib;\n4. Prior treatment with any TROP2-targeted therapy or any therapy that targets topoisomerase I (including ADCs);\n5. Other malignancies (except cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to enrollment;\n6. Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors:\n\n   1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Class III or IV heart failure \\[according to New York Heart Association (NYHA) classification\\], symptomatic or poorly controlled serious arrhythmia, cerebrovascular accident, transient ischemic attack, and other serious cardiovascular and cerebrovascular diseases within 6 months prior to enrollment;\n   2. Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy and specific cardiomyopathy;\n   3. Any peripheral arterial thromboembolic event, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic event within 3 months prior to enrollment;\n   4. Major vascular disease such as aortic aneurysm, aortic dissecting aneurysm that may be life-threatening or require surgery within 6 months prior to first dose;\n   5. Mean corrected QT interval (QTcF) between ventricular depolarization to repolarization \\> 470 ms;\n7. Uncontrolled systemic disease as judged by the investigator:\n\n   1. Poorly controlled diabetes mellitus (two consecutive fasting glucose ≥10 mmol\u002FL);\n   2. Poorly controlled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg);\n   3. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (\\> 1 time\u002Fweek);\n8. History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, or has current pneumonitis\u002FILD, or suspected pneumonitis\u002FILD that cannot be ruled out by imaging at screening;\n9. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease that prevents\u002Fdelays corneal healing;\n10. Clinically severe lung impairment caused by complications that may involve the lung, or prior pneumonectomy;\n11. Presence of active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute GI tract bleed;\n12. Active gastrointestinal disease or other conditions that significantly affect the absorption and metabolism of osimertinib (e.g., refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow drug, or previous major bowel resection);\n13. Tumor invasion or compression of surrounding important organs and blood vessels (e.g. heart, esophagus, superior vena cava, etc.) accompanied by related symptoms (e.g. superior vena cava syndrome), or presence of risk of developing esophagotracheal fistula or esophagopleural fistula;\n14. Toxicities treated by prior anti-tumor therapy having not recovered to ≤ Grade 1 (as per NCI CTCAE V5.0) or to the levels specified in the eligibility criteria;\n15. Serious infection within 4 weeks prior to enrollment or active infection requiring systemic anti-infective therapy within 2 weeks prior to enrollment;\n16. Known active tuberculosis;\n17. Presence of active hepatitis B (HBV-DNA test is required in case of hepatitis B surface antigen \\[HBsAg\\] positive; HBV-DNA ≥ 2000 IU\u002FmL or above the lower limit of detection, whichever is higher) or hepatitis C (hepatitis C antibody positive, and HCV-RNA \\> the lower limit of detection);\n18. Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n20. Major surgery within 4 weeks prior to enrollment or expected major surgery during the study;\n21. Known allergy to the study drug or any of its components, and a history of known severe hypersensitivity to other monoclonal antibodies;\n22. Medications or herbal supplements that are currently used (or cannot be discontinued prior to receiving the first dose of study treatment) and are known to be strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 (washout for at least 3 weeks);\n23. Receipt of radiotherapy at a total dose of \\>30 Gy for lung lesions within 6 months prior to enrollment; receipt of non-thoracic or extensive radiotherapy at a total dose of \\>30 Gy within 4 weeks prior to enrollment; palliative radiotherapy for symptom control is allowed, but must be completed at least 2 weeks prior to enrollment;\n24. Live vaccines inoculated within 30 days prior to enrollment or planned to be inoculated during the study;\n25. Rapid deterioration of disease, such as significant changes in performance status during the screening process prior to the first dose;\n26. Pregnant or lactating women;\n27. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study drug or the interpretation of the subject's safety or study results, or any other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study",{"count":48,"type":20},120,[50],"PHASE2","EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.",[53],"Non Small Cell Lung Cancer","2026-05-21",{"date":56,"type":31},"2026-05-26",{"date":58,"type":31},"2025-12-15",{"date":60,"type":20},"2028-12-30",{"name":37,"class":38},4,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100624640","phase-2-a-study-of-chidamide-combined-with-ivonescimab-in-the-treatment-of-advanced-non-small-cell-lung-cancer-nsclc-with-acquired-resistance-to-immunotherapy-and-high-yes-associated-protein-yap-expression-100624640","NCT07412262","A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression","A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression","NSCLC， YAP","Inclusion Criteria:\n\n1. Written informed consent must be signed before implementing any trial-related procedures;\n2. Age ≥18 years old;\n3. Have histologically or cytologically confirmed locally advanced (IIIB\u002FIIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 9th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;\n4. Previously received first-line PD-1\u002FPD-L1 inhibitor monotherapy or combination therapy, with a progression-free survival (PFS) of ≥ 6 months under the initial PD-1\u002FPD-L1-containing treatment regimen;\n5. Previously received only first-line systemic treatment;\n6. Able to provide 15 pieces of biopsied tumor tissue or tumor tissue sections after PD-1\u002FPD-L1 treatment resistance, pathologically confirmed as non-small cell lung cancer, and centrally laboratory-confirmed high YAP protein expression. Eligible subjects voluntarily provide 5-15 sections of tumor tissue samples from initial diagnosis. (YAP immunohistochemical staining intensity is graded as 0 (negative), 1+ (weak), 2+ (moderate), and 3+ (strong); the proportion of positive tumor cells is graded as 0 (0-5%), 1+ (6-25%), 2+ (26-50%), 3+ (51-75%), and 4+ (\\>75%). The YAP IHC score is calculated by multiplying the staining intensity by the proportion of positive tumor cells: YAP IRS = Staining Intensity (A) × Proportion of Positive Tumor Cells (B). A YAP IHC score \\\u003C 6 indicates low YAP expression, and ≥ 6 indicates high YAP expression);\n7. Asymptomatic brain metastasis patients are eligible for enrollment;\n8. Palliative radiotherapy completed within 2 weeks before study enrollment is allowed, and radiotherapy-related toxicity has recovered to ≤ Grade 1 (CTCAE 5.0). Radiated lesions are not considered evaluable lesions unless there is evidence of progression after radiotherapy;\n9. No prior use of any traditional Chinese medicine (TCM) with anti-tumor effects, or prior use of TCM with anti-tumor effects no more than 3 times (one dose counts as one time), and discontinuation of such TCM for ≥ 2 weeks before the start of study drug treatment.\n\n   Patients must meet the following laboratory test requirements at screening:\n10. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL without the use of growth factors in the past 14 days;\n11. Platelet count ≥ 80 × 10⁹\u002FL and hemoglobin ≥ 80 g\u002FL without blood transfusion in the past 14 days;\n12. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN) (patients with liver metastasis are allowed to have ALT or AST ≤ 5 × ULN);\n13. Total bilirubin ≤ 1.5 × ULN (patients with liver metastasis or biliary obstructive tumors are allowed to have ≤ 2.5 × ULN);\n14. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 45 ml\u002Fmin;\n15. ECOG performance status score of 0-1;\n16. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;\n17. Expected survival time \\> 12 weeks;\n18. Negative pregnancy test (applicable only to women of childbearing potential).\n\nExclusion Criteria:\n\n1. Have a history of severe bleeding tendency or coagulation disorders; have significant clinical bleeding symptoms within 4 weeks before enrollment, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only coughing blood without sputum, subjects with blood in sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retracted nasal blood); continuous antiplatelet or anticoagulant therapy within 14 days before the first dose;\n2. History of gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), esophagogastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose; extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea);\n3. Hypersensitivity to any study drug or its components;\n4. Exclusion of central squamous cell lung cancer invading large blood vessels;\n5. Patients who experienced Grade 3 or above immune-related adverse reactions with prior immunotherapy drugs, and investigators assess that immunotherapy has safety concerns with risks outweighing benefits;\n6. Any arterial thromboembolic event, Grade 3 or above venous thromboembolic event as specified by NCI CTCAE 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months before the first dose;\n7. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before the first dose;\n8. Complicated with severe uncontrolled concurrent infections or other severe uncontrolled comorbidities, moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.);\n9. Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \\> 1 × 10³ copies\u002FmL; hepatitis C virus RNA \\> 1 × 10³ copies\u002FmL);\n10. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n11. Clinically significant active infection, active pulmonary tuberculosis;\n12. Past or current clinically active interstitial lung disease; current active pneumonia; current radiation pneumonitis requiring hormone therapy;\n13. Evidence of severe or uncontrolled systemic diseases (e.g., severe mental or neurological diseases, epilepsy, or dementia not stably controlled by drugs; unstable or decompensated respiratory, cardiovascular, hepatic, or renal diseases; uncontrolled hypertension \\[i.e., hypertension ≥ CTCAE Grade 3 despite drug treatment\\]; hyperglycemia \\[fasting blood glucose \\> 10 mmol\u002FL\\]);\n14. Clinically significant ventricular arrhythmia within 12 months before the first dose, atrial fibrillation not stably controlled by drugs, unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2, or vascular diseases (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect the safety evaluation of study drugs (e.g., uncontrolled arrhythmia, myocardial ischemia, etc.);\n15. Past or current concurrent other malignant tumors (except for well-controlled non-melanoma cutaneous basal cell carcinoma, in situ breast\u002Fcervical cancer, and other malignant tumors that have been well-controlled without treatment for the past five years);\n16. Tumor invasion of large vascular structures (e.g., pulmonary artery, superior vena cava, or inferior vena cava) detected at screening, or obvious necrosis\u002Fcavitation, which is judged by investigators to have a high risk of bleeding;\n17. Active bleeding or taking therapeutic doses of anticoagulant drugs with a tendency to major bleeding;\n18. Clinically uncontrolled pleural effusion\u002Fascites\u002Fpericardial effusion;\n19. Currently participating in interventional clinical study treatment, or receiving other study drugs or study devices within 2 weeks before the first dose;\n20. Systemic treatment with Chinese patent medicines indicated for lung cancer or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local use for controlling pleural effusion) within 2 weeks before the first dose;\n21. History of solid organ or hematopoietic stem cell transplantation;\n22. Diagnosis of autoimmune disease and receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Note: Physiological doses of glucocorticoids (≤ 20 mg\u002Fday prednisone or equivalent) are allowed;\n23. Failure to fully recover from toxicity and\u002For complications caused by any intervention before the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia);\n24. Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1). Note: Inactivated viral vaccines for seasonal influenza administered by injection are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccines are not allowed;\n25. Pregnant or lactating women, and fertile patients unwilling to use contraceptive measures;\n26. Concurrent other malignant tumors requiring treatment;\n27. Patients judged by investigators to be unsuitable for participating in the study.",{"count":72,"type":20},32,[50],"This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of Chidamide in combination with Ivonescimab in the treatment of advanced non-small cell lung cancer with secondary immune resistance and high YAP protein expression.",[76],"Non-Small Cell Lung Cancer",[78,79],"YAP protein","Acquired immune resistance","NOT_YET_RECRUITING","2026-05-05",{"date":83,"type":31},"2026-05-08",{"date":85,"type":20},"2026-05-15",{"date":87,"type":20},"2029-03-31",{"name":37,"class":38},2,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":39},"100512827","phase-2-safety-and-efficacy-evaluation-of-serplulimab-plus-chemo-in-sclc-transformed-from-egfr-mutated-nsclc-after-treatment-100512827","NCT05957510","Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment","Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study","Inclusion Criteria:\n\n* Volunteer to participate in clinical studies.\n* Age 18-75 (including the cut-off value) when signing the Informed Consent Form (ICF)\n* Patients must provide pathological diagnosis reports and genetic testing reports before transformation, and the reports clearly indicate that they were non-small cell lung cancer containing EGFR mutations before transformation.\n* Patients must provide a pathological diagnosis report after transformation, as well as 10 unstained reports after transformation. The pathology of the patients after transformation was SCLC or high-grade neuroendocrine carcinoma or containing SCLC components.\n* Patients who have not received systemic therapy and anti-PD-1\u002FL1 and CTLA-4 therapy after tissue type transformation. Patients are allowed to receive immunotherapy before transformation, but the last line of therapy cannot contain immunotherapy.\n* The end of previous anti-tumor treatment must be more than 2 weeks from the first medication in this study, and the treatment-related AE should be recovered to CTCAE 5.0 ≤ grade 1 (except for grade 2 alopecia).\n* At least one measurable target lesion based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria identified within the four weeks leading up to the initial treatment dose\n* ECOG PS 0 or 1\n* Expected life expectancy of 12 weeks or more\n* Adequate organ function\n* The serum pregnancy test of female patients must be negative within 14 days before treatment, and effective contraceptive measures should be taken during treatment and within 6 months after treatment. Lactation is prohibited during treatment.\n* Male patients must agree to abstinence (avoid heterosexual intercourse) or take contraceptive measures.\n\nExclusion Criteria:\n\n* Patients cannot provide a pathology report after tissue type transformation.\n* Patients with a known history of severe allergies to any monoclonal antibody ( NCI-CTCAE 5.0 grade greater than grade 3 ); or known hypersensitivity to carboplatin\u002Fetoposide components.\n* Patients with known or screening findings of active central nervous system (CNS) metastases and\u002For cancerous meningitis (Exceptions will be made for patients with asymptomatic brain metastases or those who have had stable brain metastases for at least 4 weeks after treatment)\n* Patients who have received systemic therapy or other immune checkpoint inhibitors after tissue type transformation; patients who are preparing for or have previously received organ or bone marrow transplantation.\n* Any active infection requiring systemic anti-infectious therapy within 14 days before the first administration.\n* Myocardial infarction or poorly controlled arrhythmia has occurred within 6 months before the first administration; or according to the NYHA standard III-IV cardiac insufficiency or echocardiography left ventricular ejection fraction \\\u003C 50 %; or pleural effusion, pericardial effusion or ascites requiring clinical intervention.\n* Patients have uncontrolled or symptomatic hypercalcemia; Patients have poor blood pressure control; patients with deep vein thrombosis, being treated with anticoagulant or platelet therapy, or previous deep vein thrombosis or severe bleeding caused by the use of anti-angiogenic drugs; Patients with known active or suspected autoimmune diseases (Patients in a stable state who do not require systemic immunosuppressive therapy are allowed to be enrolled).\n* Patients who have been and were screened and judged by the investigator to be likely to interfere with the detection and management of suspected drug-related lung toxicity; Patients who the investigator believes have any factors that are inappropriate for participating in this trial.\n* Patients with hepatitis B; or hepatitis C patients; or syphilis screening positive; or known human immunodeficiency virus ( HIV ) positive history or HIV screening positive; known history of mental drug abuse or drug abuse.\n* Other active malignancies tumors within 5 years or concurrently.\n* Patients who were vaccinated with live or attenuated vaccines within 28 days before the first dose, or had plans to vaccinate such vaccines during the study period (but inactivated virus vaccines for seasonal influenza are allowed) or who underwent major surgery.\n* Patients with spinal cord compression who have not been radically cured by surgery and\u002For radiotherapy. Received radical radiotherapy within 3 months before the first administration.\n* Patients who were participating in other clinical studies, or who participated in any other clinical trials (including drugs and devices, etc.) and received intervention within 3 months or 5 half-lives (whichever is longer) before screening.","75 Years",{"count":99,"type":20},66,[50],"This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.",[103],"Small-cell Lung Cancer",[105],"transformed SCLC, EGFR-mutated NSCLC","2026-05-01",{"date":108,"type":31},"2026-05-06",{"date":110,"type":31},"2023-07-07",{"date":112,"type":20},"2026-12-31",{"name":37,"class":38},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100608229","phase-2-ibi351-plus-cetuximab--in-untreated-advanced-non-small-cell-lung-cancer-with-kras-g12c-mutation-100608229","NCT07198841","IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation","The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study","Inclusion Criteria\n\n1. Voluntarily participate in the study and sign the informed consent form (ICF).\n2. Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.\n3. Life expectancy ≥ 3 months.\n4. Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB\u002FIIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC) 8th edition TNM staging, and not candidates for curative concurrent chemoradiotherapy.\n5. Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n7. No prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC. Subjects who received prior adjuvant therapy are eligible provided disease recurrence occurred ≥6 months after the last dose of adjuvant therapy or the last session of radical radiotherapy.\n8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions within a prior radiation field or after local therapy can be considered target lesions if documented progression is evident.\n9. Adequate organ and bone marrow function, defined as:\n\n1）Hematopoietic: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL. No transfusion or treatment with granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin within 14 days prior to hematology tests.\n\n2）Hepatic: Total bilirubin (TBIL) \\\u003C 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × ULN. For subjects with Gilbert's syndrome, TBIL \\\u003C 2 × ULN is acceptable. For subjects with liver metastases, AST and ALT \\\u003C 5.0 × ULN is required. If direct bilirubin (DBIL) suggests extrahepatic obstruction, TBIL \\\u003C 3.0 × ULN is permitted.\n\n3）Renal: Serum creatinine (Cr) ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula) if Cr \\> 1.5 × ULN.\n\n4）Coagulation: Prothrombin time (PT) \u002F activated partial thromboplastin time (APTT) \\\u003C 1.5 × ULN and international normalized ratio (INR) \\\u003C 1.5 or within the therapeutic range for subjects on anticoagulation therapy.\n\n5）Magnesium: Serum magnesium within normal limits. 10. Toxicities from prior anti-tumor therapy must have resolved to baseline or ≤ Grade 1 (except for residual alopecia; neurotoxicity ≤ Grade 2 is acceptable). Subjects with prior immune-related endocrine adverse events (irAEs) from immunotherapy (e.g., hypothyroidism) that are asymptomatic and stably controlled with ongoing hormone replacement or physiologic doses of corticosteroids may be enrolled if the investigator judges that this will not affect study drug administration or safety assessment.\n\n11\\. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception from signing the ICF until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days (inclusive) prior to the first dose. If a urine pregnancy test result is inconclusive, a serum pregnancy test is required.\n\nExclusion Criteria\n\n1. Histologically or cytologically confirmed NSCLC with mixed small cell components or predominantly squamous cell carcinoma components.\n2. Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other genomic alterations for which NMPA-approved first-line NSCLC therapies exist.\n3. Significant cardiovascular or cerebrovascular disease, including:\n\n1）Clinically significant cardiovascular events within 6 months (e.g., myocardial infarction, angina, heart failure, severe arrhythmia) or history of angioplasty, stenting, or coronary artery bypass grafting.\n\n2）Clinically significant prolongation of the QTcF interval (QTcF \\> 470 ms for females or \\> 450 ms for males).\n\n3）Clinically significant cerebrovascular events within 3 months (e.g., cerebral hemorrhage, infarction).\n\n4\\. Active central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases). Subjects with previously treated brain metastases may be eligible if they are asymptomatic for at least 7 days after completion of radiotherapy\u002Flocal therapy without requiring steroids\u002Fanti-epileptics, OR off steroids\u002Fanti-epileptics for at least 7 days, AND judged by the investigator to have stable CNS disease.\n\n5\\. Clinically significant interstitial lung disease (ILD), radiation pneumonitis, or drug-induced pneumonitis requiring treatment; active pulmonary tuberculosis; pneumoconiosis; Grade ≥2 pneumonitis of other etiologies; or severely impaired pulmonary function (FEV1 or DLCO or DLCO\u002FVA \\\u003C40% of predicted value).\n\n6\\. Significant gastrointestinal disorders affecting drug absorption or swallowing (e.g., refractory hiccups, nausea, vomiting, severe peptic ulcer disease, liver cirrhosis, active GI bleeding).\n\n7\\. Major active or chronic infections, including:\n\n1. Active infection requiring systemic therapy.\n2. Baseline positive HIV antibody (HIV-Ab); acute or chronic active hepatitis B (defined as HBsAg and\u002For HBcAb positive AND HBV-DNA \\> 2500 copies\u002FmL or 500 IU\u002FmL); or acute or chronic active hepatitis C (HCV antibody positive AND HCV-RNA above the lower limit of quantification).\n3. Active pulmonary tuberculosis. 8. Symptomatic pleural, peritoneal, or pericardial effusions requiring repeated drainage.\n\n9\\. Poorly controlled systemic diseases despite standard therapy (e.g., hypertension: systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg; diabetes).\n\n10\\. History of other active malignancies within 2 years prior to study entry, except appropriately treated carcinoma in situ of the cervix, localized squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma.\n\n11\\. Prior treatment with any KRAS G12C inhibitor. 12. Prior treatment with cetuximab or its analogues. 13. Systemic treatment with Chinese herbal medicine with anti-tumor indications within 1 week prior to the first dose, OR systemic treatment with immunomodulatory drugs (including thymosin, interferon, interleukin; except for localized intrapleural use for effusion control) within 2 weeks prior to the first dose.\n\n14\\. Therapeutic or palliative radiotherapy (except cranial radiotherapy) or local therapy within 14 days prior to the first study dose.\n\n15\\. Any other anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, investigational drug\u002Fdevice) within 28 days or 5 half-lives (whichever is shorter) prior to the first study dose.\n\n16\\. Major surgery within 28 days prior to study entry that could affect study drug administration or assessments (excluding diagnostic biopsy).\n\n17\\. Use of known sensitive substrates of CYP2D6, CYP3A4, P-gp, or BCRP with a narrow therapeutic window within 14 days or 5 half-lives (whichever is longer) prior to the first study dose, unless agreed upon by both the investigator and sponsor.\n\n18\\. Concurrent participation in another interventional clinical trial (participation in observational studies or the follow-up phase of an interventional study is permitted).\n\n19\\. Use of immunosuppressive drugs within 4 weeks prior to the first study dose, excluding intranasal, inhaled, or topical corticosteroids; systemic corticosteroids at physiologic doses (≤10 mg\u002Fday prednisone or equivalent); or corticosteroids administered for prophylaxis of contrast media allergy.\n\n20\\. Administration of live attenuated vaccines within 4 weeks prior to the first study dose or planned during the study period.\n\nNote: Inactivated seasonal influenza vaccines administered \\>4 weeks prior are allowed; live attenuated influenza vaccines are not permitted.\n\n21\\. Known or suspected autoimmune disease, or history of autoimmune disease within 2 years prior to screening (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy in the last 2 years, hypothyroidism managed only with hormone replacement, or type 1 diabetes managed only with insulin replacement are eligible).\n\n22\\. Known history of primary immunodeficiency. 23. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n24\\. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to enrollment (implant port- or catheter-related thrombosis, or superficial venous thrombosis are not considered \"severe\").\n\n25\\. Known hypersensitivity to any component of the study drug or its formulation.\n\n26\\. Pregnant or breastfeeding women. 27. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.",{"count":122,"type":20},48,[50],"Study Design: a Phase II, single-arm, multicenter, prospective, interventional study.\n\nTarget Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation.\n\nTreatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity.\n\nPrimary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nSecondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.",[126],"Lung Cancer (Non-Small Cell)","2026-03-08",{"date":129,"type":31},"2026-03-11",{"date":131,"type":31},"2025-11-03",{"date":133,"type":20},"2028-09",{"name":37,"class":38},7,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100624932","phase-2-phoenix-ql1706-plus-chemotherapy-and-bevacizumab-in-aga-resistant-pd-l1-50-non-squamous-nsclc-100624932","NCT07416058","PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC","A Multicenter Study of Iparomlimab and Tuvonralimab (QL1706) Plus Platinum-Based Doublet Chemotherapy and Bevacizumab in PD-L1 ≥50% Non-Squamous Non-Small Cell Lung Cancer With Actionable Genomic Alterations (AGA) Resistant to Prior Targeted Therapy","PHOENIX","Inclusion Criteria:\n\nThe study will enroll adult patients (aged 18-75 years) with histologically confirmed locally advanced or metastatic NSCLC (AJCC 9th Edition, Stage IIIB-IVB), and harbor confirmed actionable driver mutations for which targeted therapies are available; these mutations are stratified as follows: EGFR (19del, L858R); ALK, ROS1, RET fusions; KRAS G12C; BRAF V600; and HER2 exon 20 insertions. Patients must have disease progression following at least one line of TKI therapy and a 2-week washout period is required for prior TKI therapy or chemotherapy. Prior immunotherapy is not permitted. PD-L1 tumor proportion score (TPS) ≥ 50%, as confirmed by central laboratory testing using the 22C3 or SP263 clone on fresh or archival tumor tissue (collected within 2 years). Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, and presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n\nExclusion Criteria:\n\n* Prior treatment with QL1706 or other investigational PD-1\u002FPD-L1\u002FCTLA-4 antibodies, unless allowed by the protocol.\n* Untreated or symptomatic central nervous system (CNS) metastases. Participants with previously treated, stable, and asymptomatic CNS metastases off steroids for at least 2 weeks before first dose may be eligible.\n* History of severe allergic reactions or hypersensitivity to monoclonal antibodies, platinum agents, pemetrexed, bevacizumab, or any excipients of the study drugs.\n* Clinically significant cardiovascular disease, including but not limited to:\n* Uncontrolled hypertension despite optimal medical management\n* New York Heart Association (NYHA) class III or IV heart failure\n* Unstable angina, myocardial infarction, or stroke within 6 months prior to enrollment\n* Significant arrhythmias requiring anti-arrhythmic therapy\n* Active or history of autoimmune disease that has required systemic treatment in the past 2 years (e.g., with disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for conditions such as vitiligo, resolved childhood asthma\u002Fatopy, or hypothyroidism on stable replacement therapy.\n* Active infection requiring systemic therapy, including known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, unless well controlled according to protocol-defined criteria.\n* Significant hemoptysis (e.g., ≥ 2.5 mL of bright red blood) within 3 months prior to enrollment or any evidence of high-risk bleeding or coagulation disorder that would contraindicate bevacizumab.\n* Major surgery within 4 weeks before first dose of study treatment or anticipated need for major surgery during the study.\n* Pregnant or breastfeeding women.\n* Any other serious medical condition, uncontrolled intercurrent illness, psychiatric illness, or social circumstance that, in the opinion of the investigator, would compromise the participant's safety, interfere with study evaluations, or preclude informed consent.",{"count":145,"type":20},61,[50],"The goal of this Phase II clinical trial (The PHOENIX Study) is to evaluate if the combination of QL1706 (Iparomlimab and Tuvonralimab), bevacizumab, and chemotherapy can treat patients with TKI-refractory, driver-gene positive (e.g., EGFR, ALK, ROS1, RET, KRAS, BRAF, HER2), non-squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (TPS ≥50%).\n\nThe main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nDoes the quadruple combination therapy improve the Objective Response Rate (ORR) compared to historical chemotherapy data? What are the secondary efficacy outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS)?\n\nIf there is a comparison group: There is no concurrent control group (this is an open-label, multi-cohort study). Researchers will compare the treatment outcomes of the participants to historical control data (standard platinum-based chemotherapy) to see if the objective response rate (ORR) improves from a historical baseline of 29% to a target of 55%.\n\nParticipants will:\n\nReceive induction therapy every 3 weeks for 4 cycles, consisting of intravenous infusions of QL1706, bevacizumab, pemetrexed, and platinum chemotherapy (cisplatin or carboplatin).\n\nReceive maintenance therapy every 3 weeks with QL1706 and bevacizumab for up to 2 years or until disease progression.\n\nUndergo regular tumor assessments (CT or MRI scans) to monitor disease status according to RECIST v1.1 criteria.\n\nProvide blood samples for safety monitoring and potential biomarker analysis.",[149],"Lung Adenocarcinoma",[151,152,153],"PD-L1","CTLA-4","QL1706","2026-02-10",{"date":156,"type":31},"2026-02-17",{"date":158,"type":20},"2026-01-31",{"date":160,"type":20},"2028-12-31",{"name":37,"class":38},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":170,"maxAge":97,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":180,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":89},"100602222","phase-2-adaptive-adjuvant-sintilimab-therapy-guided-by-mrd-adapt-lung-100602222","NCT07120698","Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)","Adaptive Adjuvant Sintilimab Therapy Guided by MRD in II-IIIB Stage NSCLC Patients With Non-pCR Pathological Response After Neoadjuvant Immunotherapy Combined With Chemotherapy: a Prospective, Multi-center, Single-arm, Phase II Trial","CTONG 2508","Inclusion Criteria:\n\n1. Signed written informed consent prior to the initiation of any trial-related procedures.\n2. Male or female aged ≥18 years and ≤75 years.\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n4. Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.\n5. Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy. All gross tumors must be completely resected at the end of surgery, and all surgical margins of the resected tumors must be negative. Systemic lymph node dissection is required.\n6. Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to the AJCC 8th edition TNM classification for lung cancer. Resectable N2 refers to non-massive (defined as short-axis diameter \\\u003C3 cm), discrete, or single-station N2 involvement. If clinically suspected of N2 or N3, pathological confirmation is recommended whenever feasible.\n7. Patients with pathological response assessment of 1%-90% residual viable tumor (RVT).\n8. No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor.\n9. No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer.\n10. Completed radical surgery for lung cancer 4-12 weeks prior to study enrollment, with pathological confirmation of R0 resection and radiological evidence of no residual tumor foci 1 month after radical surgery.\n11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n12. Life expectancy \\>6 months.\n13. Adequate organ function:\n\n1\\. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without the use of granulocyte colony-stimulating factor within the past 14 days.\n\n2\\. Platelets ≥100×10\\^9\u002FL without transfusion within the past 14 days. 3. Hemoglobin \\>9 g\u002FdL without transfusion or use of erythropoiesis-stimulating agents within the past 14 days.\n\n4\\. Total bilirubin ≤1.5× upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN).\n\n6\\. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin.\n\n7\\. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.\n\n8\\. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range are eligible if total T3 (or free T3) and free T4 are within the normal range.\n\n9\\. Cardiac enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed not clinically significant by the investigator are also eligible).\n\n14\\. For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Postmenopausal women are defined as those who have been amenorrheic for at least 1 year, or those who have undergone surgical sterilization or hysterectomy.\n\n15\\. All subjects (regardless of gender) at risk of conception must use contraception with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).\n\n16\\. Provide samples for MRD assessment (surgical tissue + blood).\n\nExclusion Criteria:\n\n1. Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been completely resected).\n2. Received adjuvant radiotherapy prior to dosing.\n3. Patients who underwent pneumonectomy.\n4. Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.\n5. Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy.\n6. Presence of unhealed surgical incisions, ulcers, or fractures.\n7. In the investigator's opinion, severe concomitant systemic diseases that may affect the subject's ability to complete the study. Subjects with positive autoimmune antibodies must be assessed and confirmed by the investigator to have no autoimmune diseases requiring systemic treatment before enrollment.\n8. Presence of primary immunodeficiency diseases.\n9. Receiving systemic corticosteroid therapy within 7 days prior to the first dose of the study (excluding intranasal, inhaled, or other topical corticosteroids). Note: The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n10. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n11. Known allergy to the active ingredient or excipients of the study drug, sintilimab.\n12. Not fully recovered from toxicities and\u002For complications caused by any prior interventions prior to the start of treatment (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia).","28 Years",{"count":172,"type":20},115,[50],"This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.",[176,177,178,179],"NSCLC (Non-small Cell Lung Cancer)","MRD","II-IIIB Stages","Adjuvant Immunotherapy",[177,181,182,183],"II-IIIB stages","NSCLC (non-small cell lung cancer)","adjuvant immunotherapy","2025-12-30",{"date":186,"type":31},"2026-01-05",{"date":188,"type":31},"2025-11-05",{"date":190,"type":20},"2029-07-26",{"name":37,"class":38},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":39},"100608212","a-real-world-study-of-ibi351-for-kras-g12c-nsclc-in-china-100608212","NCT07198620","A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China","Efficacy and Safety of IBI351 in Chinese Patients With KRAS G12C-Mutant Advanced NSCLC: A Retrospective Real-World Study","Inclusion Criteria:\n\n* Voluntarily participate in the study and provide signed informed consent.\n* Have histologically or cytologically confirmed locally advanced or metastatic NSCLC, classified according to the IASLC 8th edition Lung Cancer TNM Staging System.\n* Carry a confirmed KRAS G12C mutation via molecular testing.\n* Have received at least one dose of oral IBI-351 treatment between August 2024 and August 2025.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed mixed NSCLC with a predominant small cell or squamous cell carcinoma component.\n* Presence of EGFR sensitizing mutations, ALK rearrangements, ROS1 fusions, or other genomic alterations for which NMPA has approved first-line NSCLC therapies.",{"count":200,"type":20},600,"OBSERVATIONAL","This study is a retrospective, multicenter, real-world investigation designed to evaluate the efficacy and safety of IBI-351 in Chinese patients with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation in a real-world setting. A total of 600 patients with KRAS G12C-mutated advanced NSCLC who received treatment with IBI-351 between August 2024 and August 2025 will be retrospectively enrolled. Descriptive statistical methods will be used to summarize the baseline characteristics, demographic data, and medication profiles of the subjects. Unless otherwise specified, continuous data will be described using counts, means, standard deviations, maximum and minimum values, and medians; categorical data will be summarized using counts and percentages. The incidence of adverse events (AEs) and serious adverse events (SAEs) will be aggregated and presented as the number and percentage of affected subjects, and all AEs will be listed in detail. The primary endpoint is the objective response rate (ORR) as assessed by investigators, and descriptive statistics for ORR will be provided. For the secondary endpoints, progression-free survival (PFS) and overall survival (OS), Kaplan-Meier (K-M) analysis will be performed to estimate median values and corresponding 95% confidence intervals (CIs), and K-M curves will be generated accordingly.",[204],"Lung Cancer (NSCLC)","2025-09-22",{"date":207,"type":31},"2025-09-30",{"date":209,"type":20},"2025-10-01",{"date":211,"type":20},"2026-12-01",{"name":37,"class":38},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100603276","phase-2-ql1706bevacizumab--chemotherapy-in-post-ici-non-squamous-nsclc-100603276","NCT07134413","QL1706\u002FBevacizumab ± Chemotherapy in Post-ICI Non-Squamous NSCLC","Efficacy and Safety of QL1706 and Bevacizumab With or Without Chemotherapy in Patients With Non-Squamous Non-Small Cell Lung Cancer Previously Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n1. Signed an informed consent form\n2. Patients aged ≥18\n3. Histologically or cytologically confirmed stage III or IV non-squamous non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) 8th Edition staging system\n4. at least one measurable lesion according to RECIST 1.1 criteria\n5. ECOG PS 0-1.\n6. Subjects must have adequately documented disease progression following prior treatment with PD-1\u002FPD-L1 inhibitors (administered as monotherapy or in combination with chemotherapy)\n\n8\\. The most recent tumor tissue sample prior to the first dose of the study drug demonstrated PD-L1 TPS \\\u003C1% 9. appropriate organ function\n\nExclusion Criteria:\n\n1. Known presence of sensitizing mutations in EGFR, EGFR exon 20 insertions, ALK fusions, ROS1 fusions, RET fusions, NTRK fusions, BRAF V600E mutations, MET exon 14 skipping mutations, or HER2 sensitizing mutations (for other genetic alterations, eligibility will be determined by the Biomarker Committee on a case-by-case basis).\n2. Patients with symptomatic, neurologically unstable central nervous system (CNS) metastases, or CNS diseases that require increased steroid doses to control\n3. Prior lines of systemic anti-tumor therapy ≥ 2.",{"count":221,"type":20},77,[50],"The goal of this clinical trial is to evaluate QL1706 plus bevacizumab with or without chemotherapy in patients with PD-L1-negative, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) previously treated with immune checkpoint inhibitors (ICIs). The primary objectives are:\n\nTo assess the efficacy and safety of QL1706 combined with bevacizumab (± chemotherapy) in this population.\n\nEligible patients with PD-L1-negative, locally advanced or metastatic non-squamous NSCLC who progressed after prior PD-1\u002FPD-L1 inhibitor therapy will be assigned to one of two treatment arms at the investigator's discretion:\n\nArm 1: QL1706 + bevacizumab + chemotherapy (target enrollment: 67 subjects). Single-agent chemotherapy (selected from regimens not previously received) will be administered, with options including nab-paclitaxel, pemetrexed, or docetaxel.\n\nArm 2: QL1706 + bevacizumab (target enrollment: 10 subjects).",[26],[226,153,227,26],"iparomlimab and tuvonralimab","Checkpoint inhibitor","2025-08-14",{"date":230,"type":31},"2025-08-21",{"date":232,"type":20},"2025-08",{"date":234,"type":20},"2029-07",{"name":37,"class":38},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100582061","phase-3-lorlatinib-compared-with-concurrent-sequential-chemoradiotherapy-in-stage-iii-alk-positive-lung-adenocarcinoma-100582061","NCT06858410","Lorlatinib Compared with Concurrent\u002F Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma","A Randomized, Open-label, Multicenter, Phase III Study of Lorlatinib Compared with Concurrent\u002F Sequential Chemoradiotherapy As Definitive Treatment in Patients with Locally Advanced, Unresectable Stage III ALK Positive Lung Adenocarcinoma","Inclusion Criteria:\n\n* Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \\[IASLC\\]).\n* Tumor Requirements: At least 1 measurable target lesion per RECIST v. 1.1\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. Life expectancy at least 12weeks at Day1.\n* Age ≥18 years.\n* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Previously received any ALK-TKIs or any thoracic radiotherapy\n* Active infection, including Bacteria, fungi or viruses\n* Any evidence of severe or uncontrolled systemic diseases, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol\n* Inadequate bone marrow reserve or organ function.\n\n  1. Absolute neutrophil count \\\u003C1.5\\*109\u002FL\n  2. Platelet count \\\u003C90\\*109\u002FL\n  3. Hemoglobin \\\u003C90 g\u002FL (\\\u003C9 g\u002FdL) d Alanine aminotransferase \\> 3 times the upper limit of normal (ULN)\n\n  e. Aspartate aminotransferase \\> 3 times the upper limit of normal (ULN) f. Total bilirubin \\> 1.5\\*ULN g. Creatinine \\>1.5\\*ULN or creatinine clearance \\\u003C45 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n* History of interstitial lung disease (ILD) or active ILD or pneumonia\n* Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib.\n* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and\u002For during study participation.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements",{"count":244,"type":20},36,[246],"PHASE3","The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or concurrent\u002Fsequential platinum-based chemoradiotherapy",[249],"Neoadjuvant Non-Small Cell Lung Cancer",[251,252,149,26],"ALK-positive","Stage III unresectable","2025-02-27",{"date":255,"type":31},"2025-03-05",{"date":257,"type":20},"2025-03",{"date":259,"type":20},"2030-08",{"name":37,"class":38},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":5},"100570594","minimal-residual-disease-guiding-adjuvant-therapy-in-stage-i-nsclc-100570594","NCT06709274","Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC","Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study","MOTION-NSCLC","Inclusion Criteria:\n\n1. Non-small cell lung cancer (NSCLC) confirmed by histological and\u002For cytological examination. Invasive subtypes are required for adenocarcinomas.\n2. Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer\u002FAmerican Joint Committee on Cancer (8th Edition).\n3. Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.\n4. Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Minimum life expectancy of ≥12 weeks.\n7. Demonstrate adequate organ function, including:\n\n   Hematological parameters:\n   * Absolute neutrophil count ≥1.5×10\\^9\u002FL\n   * Platelet count ≥100×10\\^9\u002FL\n   * Hemoglobin ≥90 g\u002FL\n\n   Liver function:\n   * ALT ≤2.5× upper limit of normal (ULN)\n   * AST ≤2.5×ULN\n   * Total Bilirubin (TBL) ≤1.5×ULN Renal function: Creatinine level ≤1.25×ULN, or creatinine clearance ≥60 mL\u002Fmin (measured or calculated using the Cockcroft-Gault formula).\n8. Male or female, age between 18 and 75 years.\n9. Written informed consent must be obtained from the subject or their legal representative.\n10. Participants regardless of sex must agree to use effective contraception during the study period and for 3 months following treatment completion.\n11. Willingness and ability to comply with visit schedules, treatment plans, and laboratory assessments.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed small cell carcinoma components.\n2. Presence of multiple pulmonary nodules.\n3. Incomplete resections (R1\u002FR2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.\n4. A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n5. Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.\n6. Previous use of any traditional Chinese medicine with anti-tumor properties, or use of such medicine within 2 weeks prior to surgery.\n7. History of other malignancies within the past 5 years, with the exception of the following:\n\n   * Other malignancies fully cured by surgery with a disease-free survival of more than 10 years\n   * Curable basal cell carcinoma of the skin\n   * Bladder carcinoma in situ\n   * Cervical carcinoma in situ\n8. History of interstitial lung disease, drug-induced interstitial lung disease, radiation-induced pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease.\n9. Active hepatitis B, defined as HBsAg positive with an HBV-DNA copy number exceeding the ULN established by the study center, accompanied by abnormal liver function, or requiring treatment as evaluated by the investigator.\n10. Presence of any unstable systemic disease, including but not limited to active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past 3 months, serious arrhythmias that requires medication, liver disease, kidney disease, or metabolic disorders.\n11. Evidence of any other diseases, neurological or metabolic disorders, or physical exam or laboratory findings that may suggest contraindications for the investigational drug, or a high risk for treatment-related complications.\n12. Any of the following cardiac conditions:\n\n    * Resting ECG QT interval (QTc) \\> 470 msec.\n    * Significant abnormalities in rhythm, conduction, or morphology on resting ECG, including complete left bundle branch block, third-degree atrioventricular block, or second-degree atrioventricular block\n    * Factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under the age of 40, or use of medications known to prolong QT interval.\n13. Blood transfusion within 2 weeks prior to and during the surgery.\n14. History of alcohol or drug abuse.\n15. Pregnant or breastfeeding females.\n16. Any other factors that the investigator deems may affect the progress of the study or compromise the trial data",{"count":270,"type":20},342,[23],"This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.",[76],"2024-11-27",{"date":276,"type":31},"2024-11-29",{"date":278,"type":20},"2024-11",{"date":280,"type":20},"2032-01",{"name":37,"class":38},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":39},"100523166","phase-2-lorlatinib-as-the-first-line-treatment-in-china-advanced-alk-nsclc-100523166","NCT06092086","Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC","A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in The First-Line Treatment of Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nInclusion Criteria of CROWN Criteria (CC) Cohort\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Diagnosis:\n\n   1. Study Population: Patients with histologically or cytologically confirmed diagnosis of locally advanced \\[(Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) by American Joint Committee on Cancer (AJCC) v 7.0\\] ALK-positive NSCLC where ALK status is determined by the Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC test performed on the Ventana ULTRA or XT Platforms, FISH, PCR, or next generation sequencing (NGS), or circulating tumor DNA (ctDNA).\n   2. Tumor Requirements: At least 1 extracranial measurable target lesion per RECIST v. 1.1 that has not been previously irradiated. CNS metastases are allowed if asymptomatic and:\n\n      1. Either untreated and not currently requiring corticosteroid treatment, or on a stable or decreasing dose of ≤10 mg QD prednisone or equivalent; or\n      2. Local treatment has been completed with full recovery from the acute effects of radiation therapy or surgery prior to randomization, and if corticosteroid treatment for these metastases has been withdrawn for at least 4 weeks with neurological stability; or\n      3. In case of leptomeningeal disease (LMD) or carcinomatous meningitis (CM) if visualized on magnetic resonance imaging (MRI), or if baseline CSF positive cytology is available.\n   3. Tissue Requirements: All patients must have an archival formalin fixed, paraffin embedded (FFPE) tissue specimen available and collected prior to randomization. If archived tissue is unavailable, then a mandatory de novo biopsy must be performed.\n2. No prior systemic NSCLC treatment for advanced (Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) disease, including molecularly targeted agents (e.g., ALK TKIs), angiogenesis inhibitors, immunotherapy, or chemotherapy. Prior treatment for earlier Stages of the NSCLC only allowed if completed more than 12 months prior to randomization.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.\n4. Age ≥18 years.\n5. Adequate Bone Marrow Function, including:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 or ≥1.5 x 109\u002FL;\n   2. Platelets ≥100,000\u002Fmm3 or ≥100 x 109\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL.\n6. Adequate Pancreatic Function, including:\n\n   1. Serum total amylase ≤1.5 x upper limit of normal (ULN)\\*;\n   2. Serum lipase ≤1.5 x ULN. \\*if total amylase \\>1.5 x ULN, but pancreatic amylase is within the ULN, then patient may be enrolled.\n7. Adequate Renal Function, including:\n\n   a. Serum creatinine ≤1.5 x ULN or estimated creatinine clearance ≥60 mL\u002Fmin as calculated using the method standard for the institution.\n8. Adequate Liver Function, including:\n\n   1. Total serum bilirubin ≤1.5 x ULN;\n   2. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 x ULN (≤5.0 x ULN in case of liver metastases).\n9. Acute effects of prior radiotherapy resolved to baseline severity or to CTCAE Grade ≤1 except for AEs that in the investigator's judgment do not constitute a safety risk for the patient.\n10. Serum pregnancy test (for females of childbearing potential) negative at screening. Female patients of non-childbearing potential must meet at least 1 of the following criteria:\n\n    1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause (which may be confirmed with a serum follicle-stimulating hormone \\[FSH\\] level confirming the postmenopausal state if appropriate);\n    2. Have undergone a documented hysterectomy and\u002For bilateral oophorectomy;\n    3. Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.\n11. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n12. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n\nInclusion Criteria of Compassionate use (CU) Cohort\n\n1. Diagnosed as ALK-positive NSCLC as in CC cohort, but not fulfilled CC cohort inclusion criteria 2\\~9 as above mentioned.\n2. No prior ALK TKI treatment for advanced (Stage IIIB\u002FC not amenable for multimodality treatment) or metastatic (Stage IV) disease (e.g., alectinib, brigatinib).\n3. Serum pregnancy test (for females of childbearing potential) negative at screening.\n4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n5. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following characteristics\u002Fconditions will not be included in this clinical study:\n\n1. Spinal cord compression unless the patient has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks prior to randomization.\n2. Major surgery within 4 weeks prior to randomization. Minor surgical procedures (e.g., port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.\n3. Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Patients who complete whole brain irradiation within 4 weeks prior to randomization or palliative radiation therapy outside of the CNS within 48 hours prior to randomization will also not be included in the study.\n4. Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes.\n5. Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations.\n6. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (e.g., in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.\n7. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but are not limited to:\n\n   1. Arterial disease such as cerebral vascular accident\u002Fstroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;\n   2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary embolism;\n   3. Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR \\>220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as \\\u003C50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc \\>470 msec, or congenital long QT syndrome.\n8. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g., uncontrolled hyperglycemia, current gallstone disease) in the last month prior to randomization.\n9. History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis.\n10. Evidence of active malignancy (other than NSCLC, non-melanoma skin cancer, or localized prostate cancer or any in situ cancer which does not currently require treatment) within the last 3 years prior to randomization.\n11. Concurrent use of any of the following food or drugs (consult the sponsor if in doubt whether a food or a drug falls into any of the above categories) within 12 days prior to the first dose of lorlatinib.\n\n    1. Known strong CYP3A inhibitors (e.g., strong CYP3A inhibitors: grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits \\[eg, Seville oranges, pomelos\\], boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, ritonavir alone and with danoprevir or elvitegravir or indinavir or lopinavir or paritaprevir or ombitasvir or dasabuvir or saquinavir or tipranavir, telaprevir, troleandomycin, and voriconazole. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n    2. Known CYP3A substrates with narrow therapeutic index, such as astemizole\\*, terfenadine\\*, cisapride\\*, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl (including transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine) (\\*withdrawn from US market).\n    3. Known strong CYP3A inducers (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort). d. Known P-gp substrates with a narrow therapeutic index (e.g., digoxin).\n12. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n14. Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and\u002For during study participation.\n15. Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib.",{"count":290,"type":20},126,[50],"This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC). Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.",[294],"ALK Positive Non-small Cell Lung Cancer","2023-10-19",{"date":297,"type":31},"2023-10-23",{"date":299,"type":31},"2023-08-18",{"date":301,"type":20},"2030-08-01",{"name":37,"class":38},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100480478","phase-2-adjuvant-treatment-based-on-mrd-for-egfr-mutant-nsclc-100480478","NCT05536505","Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC","Adjuvant Treatment Based on Minimal Residual Disease for Resectable Non-squamous Non-Small-Cell-Lung-Cancer With EGFR Mutations","Inclusion Criteria:\n\n1. Written informed consent provided.\n2. Males or females aged ≥18 years, \\\u003C 80 years.\n3. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.\n4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation.\n5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy.\n6. ECOG performance status 0-1.\n7. Life expectancy ≥12 weeks.\n8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109\u002FL, and Platelet count ≥100 x 109\u002FL, and Hemoglobin ≥9 g\u002FdL (may be transfused to maintain or exceed this level).\n9. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.\n10. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml\u002Fmin.\n11. Female subjects should not be pregnant or breast-feeding.\n\nExclusion Criteria:\n\n1. Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product.\n2. Inability to comply with protocol or study procedures.\n3. A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.\n4. A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.\n5. Interstitial pneumonia.\n6. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab).\n7. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).\n8. Patients with prior radiotherapy to primary lesion or lymph nodes.\n9. History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.\n10. Any unstable systemic disease (including active infection, uncontrolled hypertension (systolic pressure \\> 160mmHg, diastolic pressure \\> 100mmHg), unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).\n11. Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.\n12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.\n13. Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) Patients who harboring exon 20 T790M mutation, EGFR 20 insertions, ALK fusion, BRAF V600E mutation, MET amplification and KRAS mutation.","80 Years",{"count":312,"type":20},180,[50],"A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).",[177],[26,317,318],"Adjuvant","EGFR mutation","2022-09-12",{"date":321,"type":31},"2022-09-14",{"date":323,"type":31},"2022-09-13",{"date":325,"type":20},"2030-10-01",{"name":37,"class":38},16,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":39},"100289327","local-therapy-in-advanced-nsclc-with-non-progressive-disease-pd-after-first-line-therapy-100289327","NCT03046316","Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy","Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy","LOCAL","Inclusion Criteria:\n\n* Male or female, age \\>= 18 years, with life expectancy of at least 12 weeks.\n* Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.\n* Subjected to driving genes examination including EGFR, ALK and ROS1.\n* Achieve complete response (CR)\u002Fpartial response (PR)\u002Fstable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).\n* Total metastatic lesions is limited to five.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \\\u003C= 2.\n* Patients must have measurable disease according to the RECIST (version 1.1) criteria.\n* Adequate organ function as defined by the following criteria:\n\n  * Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C= 2.5 upper limit of normal (ULN) in the absence of liver metastases or up to 5 ULN in case of liver metastases. Total bilirubin \\\u003C= 1.5 ULN.\n  * Bone marrow function: Granulocyte count \\>= 1,500\u002Fmm3 and platelet count ≥100,000\u002Fmm3 and hemoglobin \\>= 80g\u002Fdl.\n  * Renal function: serum creatinine \\\u003C= 1.5 ULN or creatinine clearance \\>= 60 ml\u002Fmin. (based on modified Cockcroft-Gault formula).\n  * Adequate coagulating function.\n* For all females of childbearing potential a negative serum\u002Furine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Males must agree to use effective contraception during the study period and for at least 12 weeks after completion of the study treatment.\n* Written (signed) informed Consent to participate in the study.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.\n* Patients with PFS no more than 3 months. to first line theray.\n* Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).\n* Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.\n* Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.\n* Patients with any unstable systemic disease (including active infections, significant cardiovascular disease, any significant hepatic, renal or metabolic disease).\n* Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.\n* Nursing or lactating women.\n* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.\n* Patients who has mental disorder or other disease that contribute to no compliance.\n* Unwilling to write informed consent to participate in the study.\n* Patients who is unwilling to accept the follow-up.",{"count":337,"type":20},60,[23],"This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III\u002FIV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).",[341],"Lung Neoplasms",[343,344],"Therapeutics","local therapy","2020-07-21",{"date":347,"type":31},"2020-07-23",{"date":349,"type":31},"2020-06-01",{"date":351,"type":20},"2026-07-01",{"name":37,"class":38},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":39},"100384526","the-real-world-study-of-neoadjuvant-immunotherapy-in-early-stage-nsclc-in-china-100384526","NCT04286841","The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China","Inclusion Criteria:\n\n* Written informed consent provided\n* Males or females aged ≥18 years\n* Able to comply with the required protocol and follow-up procedures、\n* Pathologically diagnosed of potentially resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)\n* Measurable disease must be characterized according to RECIST 1.1 criteria\n* ECOG performance status 0-1\n* Regardless of PD-L1 expression\n* EGFR mutation (-) and ALK translocation (-)\n* Pulmonary function could be well tolerated by lobectomy or pneumonectomy\n\nExclusion Criteria:\n\n* EGFR mutation (+) or ALK translocation (+)\n* Active Central nervous system (CNS) metastases\n* Patients with active, known or suspected autoimmune disease.\n* Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment\n* Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and\u002For poor lung function. Patients with other active malignancy requiring concurrent intervention and\u002F or concurrent treatment with other investigational drugs or anti-cancer therapy\n* Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical\u002F dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period\n* Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information\n* Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Patients with positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating active hepatitis\n* Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Patients with history of allergy to study drug components excipients\n* Women who are pregnant or in the period of breastfeeding\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study\n* In case of doubt please contact trial team.",{"count":360,"type":20},100,"Several published clinical trials have shown the superiority of immunotherapy in neoadjuvant setting. Here we conducted this real world study to see whether neoadjuvant immunotherapy would bring MPR and survival benefits in NSCLC, for example, single agent immunotherapy or immunotherapy combination with chemotherapy. Furthermore biomarker analysis would be also performed to achieve personalized neoadjuvant immunotherapy.",[363,364],"Immunotherapy","Lung Cancer",[366,26],"neoadjuvant immunotherapy","2020-02-25",{"date":369,"type":31},"2020-02-27",{"date":371,"type":31},"2019-05-01",{"date":373,"type":20},"2029-12",{"name":37,"class":38},""]