Clinical trial · Interventional
Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer
NCT07153770CI-TRIAL-00094522not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MET Activating Mutation | — | UNRESOLVED | — |
| MET Exon 14 Mutation | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bozitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bozitinib group
- description
- 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.
- interventionNames
- Drug: Bozitinib
Primary outcomes (1)
- measure
- Major Pathological Response
- timeFrame
- Up to 6 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to participate in this study: * 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. * Hepatic function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with HCC, liver metastases, or history/suspected 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. * Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min; urine dipstick protein \< 2+. * Coagulation: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN. Thyroid 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. * Cardiac enzymes: within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable). * 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). All subjects with potential risk of pregnancy (male or female) must use highly effective contraception with a failure rate \<1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy). Exclusion Criteria: * 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). * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.