[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604765":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":34,"acronym":19,"eligibilityCriteria":35,"healthyVolunteers":32,"sex":36,"minAge":37,"maxAge":19,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":51,"whyStopped":19,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":19},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bozitinib group","EXPERIMENTAL","Participants will receive bozitinib in combination with standard platinum-based doublet chemotherapy for 8 weeks. Following investigator-assessed operability, surgical resection will be performed approximately 4 weeks after completion of neoadjuvant therapy. The first MRD assessment will be conducted after completion of neoadjuvant therapy and before surgery.A second MRD assessment will be performed within 7 days to 1 month after surgery. Based on a comprehensive evaluation of MRD status, tumor markers, and imaging results, if molecular abnormalities are detected., patients will receive bozitinib within 3 months after surgery. If CEA remains within the normal range and blood cfDNA-MRD is negative, patients will enter a regular follow-up program, with MRD assessments every 3 months during the first 2 years and every 6 months from years 3 to 5. If MRD conversion to positive, abnormal CEA, or abnormal CT findings occur within 5 within 5 years, bozitinib will be administered.",[13],"Drug: Bozitinib",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Bozitinib",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Chunxia Su, Phd","CONTACT","021-65115006","susu_mail@126.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Chunxia Su","Professor","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":39,"type":40},34,"ESTIMATED","INTERVENTIONAL",[43],"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",[46,47,48],"NSCLC","MET Exon 14 Mutation","MET Activating Mutation",[46,17,50],"Radical Treatment","NOT_YET_RECRUITING","2025-08-26",{"date":54,"type":55},"2025-09-04","ACTUAL",{"date":57,"type":40},"2025-09-20",{"date":59,"type":40},"2028-09-20",{"name":5,"class":6}]