[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"met-activating-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:met-activating-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100604765","phase-2-bozitinib-combined-with-chemotherapy-as-radical-treatment-for-stage-iia-iiic-met-altered-non-small-cell-lung-cancer-100604765",false,"NCT07153770","Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to participate in this study:\n* Signed informed consent.\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed NSCLC adenocarcinoma, with -postoperative pathology confirming stage IIA-IIIC.\n* Willing to undergo curative resection, and assessed by a surgeon as operable with no surgical contraindications.\n* No prior systemic anti-tumor therapy.\n* Expected survival ≥ 6 months.\n* At least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2.\n* MET alteration confirmed by NGS gene testing, including the following types:\n\nMET exon 14 skipping mutation (NGS results from tissue or blood sample certified by CLIA or CAP).\n\n* MET primary amplification, NGS positive or FISH GCN ≥6 (results from tissue or blood sample certified by CLIA or CAP or FISH assay).\n* MET protein overexpression, immunohistochemistry showing ≥50% tumor cells with ++ or higher staining.\n* Adequate pulmonary function to tolerate surgery.\n* Adequate organ and bone marrow function, defined as:\n* Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelets ≥ 100 × 10⁹\u002FL; hemoglobin ≥ 9.0 g\u002FdL.\n* Hepatic function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with HCC, liver metastases, or history\u002Fsuspected Gilbert syndrome (persistent or recurrent hyperbilirubinemia, mainly unconjugated, without evidence of hemolysis or liver lesions), TBIL ≤ 3 × ULN; for patients without HCC or liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL\u002Fmin; urine dipstick protein \\\u003C 2+.\n* Coagulation: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN.\n\nThyroid function: normal thyroid-stimulating hormone (TSH); if baseline TSH is outside the normal range, enrollment is allowed if total T3 (or FT3) and FT4 are within normal limits.\n\n* Cardiac enzymes: within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable).\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If urine pregnancy test cannot be confirmed negative, a serum pregnancy test is required. Non-childbearing females are defined as postmenopausal for at least 1 year, or surgically sterile (bilateral oophorectomy or hysterectomy).\n\nAll subjects with potential risk of pregnancy (male or female) must use highly effective contraception with a failure rate \\\u003C1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria are not eligible for this study:\n\nPresence of EGFR, ALK, ROS1, or other actionable mutations excluding MET. Receipt of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.\n\n* All participants must undergo brain imaging (MRI or contrast-enhanced CT) prior to enrollment to rule out brain metastases.\n* Major surgery (e.g., thoracic, abdominal, or pelvic) within 4 weeks prior to study treatment initiation, or ongoing recovery from surgical complications.\n\nDiagnosis of any malignancy other than NSCLC within 5 years prior to study treatment initiation (excluding completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ carcinoma, or completely resected papillary thyroid carcinoma).\n\n* Active, known, or suspected autoimmune disease.\n* Known history of primary immunodeficiency.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug bozitinib, platinum-based doublet chemotherapy, or any excipients.\n* Not fully recovered from any toxicity and\u002For complications caused by prior interventions (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) prior to study treatment.\n* Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory).\n\nNote: Patients with hepatitis B meeting the following criteria may be enrolled:\n\nHBV viral load \\\u003C1000 copies\u002FmL (200 IU\u002FmL) prior to first dose; patients must receive antiviral therapy throughout chemotherapy to prevent viral reactivation.\n\nPatients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation.\n\n* Active hepatitis C infection (HCV antibody positive and HCV-RNA above the assay lower limit of detection).\n* Any history, condition, treatment, or laboratory abnormality that could interfere with study results, hinder full participation, or that the investigator considers a potential risk or inappropriate for enrollment.","ALL","18 Years",{"count":18,"type":19},34,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study aim to evaluate the efficacy and safety of Bozitinib combined with chemotherapy as radical treatment for stage IIA-IIIC MET-altered non-small cell lung cancer",[25,26,27],"NSCLC","MET Exon 14 Mutation","MET Activating Mutation",[25,29,30],"Bozitinib","Radical Treatment","NOT_YET_RECRUITING","2025-08-26",{"date":34,"type":35},"2025-09-04","ACTUAL",{"date":37,"type":19},"2025-09-20",{"date":39,"type":19},"2028-09-20",{"name":41,"class":42},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER"]