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
Signed informed consent.
Age ≥ 18 years.
Histologically or cytologically confirmed NSCLC adenocarcinoma, with -postoperative pathology confirming stage IIA-IIIC.
Willing to undergo curative resection, and assessed by a surgeon as operable with no surgical contraindications.
All participants must undergo brain imaging (MRI or contrast-enhanced CT) prior to enrollment to rule out brain metastases.
Major surgery (e.g., thoracic, abdominal, or pelvic) within 4 weeks prior to study treatment initiation, or ongoing recovery from surgical complications.
Active, known, or suspected autoimmune disease.
Known history of primary immunodeficiency.
Single group
Bozitinib
DrugParticipants 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.
Major Pathological Response
defined as the proportion of patients who achieve a major pathological response among all patients undergoing surgical pathological assessment. Major pathological response is defined as ≤10% viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by hematoxylin and eosin (H\&E) staining.
Objective Response Rate
defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) among all patients.
Pathological Complete Response rate
defined as the proportion of patients who achieve a pathological complete response among all patients undergoing surgical pathological assessment. Pathological complete response is defined as the absence of any residual viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by hematoxylin and eosin (H\&E) staining.
Disease Control Rate
defined as the proportion of patients who achieve stable disease (SD), partial response (PR), or complete response (CR) among all patients.
Event-Free Survival
defined as the time from randomization to disease progression precluding surgery, local or distant disease recurrence, or death from any cause, whichever occurs first.
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