Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer

NCT07153770 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025LY0214
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

NSCLC; MET Exon 14 Mutation; MET Activating Mutation

Keywords

NSCLC; Bozitinib; Radical Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 month

Secondary Outcomes (6)

• Objective Response Rate

  Up to 6 month

• Pathological Complete Response rate

  Up to 6 month

• Disease Control Rate

  Up to 2 year

• Event-Free Survival

  Up to 2 year

• 3-Year Overall Survival

  Up to 3 year

Study Arms (1)

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.

Drug: Bozitinib

Interventions

Bozitinib DRUG

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.

Bozitinib group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior systemic anti-tumor therapy.
• Expected survival ≥ 6 months.
• At least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2.
• MET alteration confirmed by NGS gene testing, including the following types:
• MET exon 14 skipping mutation (NGS results from tissue or blood sample certified by CLIA or CAP).
• MET primary amplification, NGS positive or FISH GCN ≥6 (results from tissue or blood sample certified by CLIA or CAP or FISH assay).
• MET protein overexpression, immunohistochemistry showing ≥50% tumor cells with ++ or higher staining.
• Adequate pulmonary function to tolerate surgery.
• Adequate organ and bone marrow function, defined as:
• Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L; hemoglobin ≥ 9.0 g/dL.

You may not qualify if:

• Patients meeting any of the following criteria are not eligible for this study:
• Presence 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.
• 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.
• Diagnosis 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).
• Active, known, or suspected autoimmune disease.
• Known history of primary immunodeficiency.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to the study drug bozitinib, platinum-based doublet chemotherapy, or any excipients.
• Not fully recovered from any toxicity and/or complications caused by prior interventions (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) prior to study treatment.
• Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory).
• Note: Patients with hepatitis B meeting the following criteria may be enrolled:
• HBV viral load \<1000 copies/mL (200 IU/mL) prior to first dose; patients must receive antiviral therapy throughout chemotherapy to prevent viral reactivation.
• Patients 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.
• Active hepatitis C infection (HCV antibody positive and HCV-RNA above the assay lower limit of detection).

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Central Study Contacts

Chunxia Su, Phd

CONTACT

021-65115006; susu_mail@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE