Resectable stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) with c-MET exon 14 skipping mutation
Conditions
Interventions
experimental group:Vebreltinib 200mg twice a day orally, used for 8 weeks
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Sign Informed Consent 2. Age >= 18 Years Old 3. Histology Or Cytology Confirmed Nsclc, With A Clear Diagnosis Of Stage IIA-IIIB (N2) 4. Agree To Undergo Radical Surgery, And Assessed By A Surgeon As Operable With No Surgical Contraindications 5. No Prior Anti-Tumor Treatment Before Radical Surgery 6. Expected Survival Time >= 6 Months 7. According To Recist V1.1, At Least One Measurable Or Evaluable Lesion 8. Ecog Performance Status Score 0-2 9. Met Exon 14 Skipping Mutation Confirmed By Ngs (Tissue/Blood Ngs Results Accepted From Clia Or Cap Certified Labs) 10. Good Lung Function, Expected To Tolerate Surgery 11. Adequate Organ And Bone Marrow Function, Defined As: a) Blood Routine: Absolute Neutrophil Count >= 1.5×10^9/L; Platelet Count >= 100×10^9/L; Hemoglobin >= 9.0 G/DL b) Liver Function: Total Bilirubin (Tbil) = 50 Ml/Min; Urine Test Shows Protein < 2+ d) Coagulation: Aptt And Inr <= 1.5×Uln e) Normal Thyroid Function, Defined As Tsh Within Normal Range. If Baseline Tsh Is Out Of Range, Subjects With Total T3 (Or Ft3) And Ft4 Within Normal Range Can Also Enroll f) Cardiac Enzymes Within Normal Range (Isolated Lab Abnormalities Deemed Clinically Insignificant By Investigator Are Acceptable) 12. Women Of Childbearing Potential Should Have A Negative Urine Or Serum Pregnancy Test Within 3 Days Before The First Study Drug Dose (Cycle 1, Day 1). If Urine Pregnancy Test Cannot Be Confirmed Negative, A Blood Test Is Required. Non-Childbearing Women Are Defined As Postmenopausal For At Least One Year Or Having Undergone Sterilization Or Hysterectomy 13. All Subjects At Risk Of Pregnancy (Male Or Female) Must Use Contraception With A Failure Rate Of Less Than 1% During Treatment And Until 120 Days After The Last Study Drug Dose (Or 180 Days After The Last Chemotherapy Dose)
Exclusion criteria
Exclusion criteria: 1. Patients Detected With EGFR/ALK/ROS1 Or Other Driver Gene Mutations Except MET Mutation 2. Received Live Attenuated Vaccines Within 4 Weeks Prior To Enrollment, Or Plan To Receive Live Attenuated Vaccines During The Study Period 3. Brain Metastases Confirmed Via Brain Contrast-Enhanced MRI Or CT Performed At Screening 4. Received Major Surgeries (Thoracic, Abdominal, Pelvic Surgery Etc.) Within 4 Weeks Before Initiation Of Study Treatment, Or Postoperative Adverse Reactions Have Not Been Resolved 5. Diagnosed With Other Malignant Tumors Within 5 Years Before Study Treatment Initiation (Exceptions: Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma And Carcinoma In Situ Completely Resected And Cured; Subjects With Radical Resected Papillary Thyroid Carcinoma Are Eligible For Enrollment) 6. Active, Confirmed Or Suspected Autoimmune Diseases 7. Confirmed History Of Primary Immunodeficiency Disease 8. History Of Allogeneic Solid Organ Transplantation Or Allogeneic Hematopoietic Stem Cell Transplantation 9. Confirmed Hypersensitivity To The Active Pharmaceutical Ingredient Or Any Excipients Of The Investigational Drug 10. Toxicities And Complications Induced By Prior Anti-Tumor Interventions Have Not Fully Recovered To Grade =2 Chronic Heart Failure c) Any Arterial Thrombosis, Embolism Or Ischemic Events Occurred Within 6 Months Before Enrollment, Including Myocardial Infarction, Unstable Angina, Cerebrovascular Accident, Transient Ischemic Attack d) Uncontrolled Hypertension (Systolic Blood Pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg) e) History Of Non-Infectious Pneumonia Requiring Glucocorticoid Therapy Within 1 Year Prior To First Dosing, Or Currently Active Interstitial Lung Disease f) Active Pulmonary Tuberculosis g) Active Uncontrolled Infections Requiring Systemic Anti-Infective Therapy h) Clinically Active Diverticulitis, Intra-Abdominal Abscess Or Gastrointestinal Obstruction i) Hepatic Cirrhosis, Decompensated Liver Disease, Acute Or Chronic Active Hepatitis j) Poorly Controlled Diabetes Mellitus (Fasting Blood Glucose > 10 mmol/L) k) Urinalysis Indicating Significant Proteinuria With 24-Hour Urine Protein Quantification > 1.0 g l) Psychiatric Disorders Rendering Subjects Unable To Comply With Trial Procedures m) Active Hemorrhagic Diseases, New-Onset Thrombotic Diseases, Receiving Therapeutic Anticoagulants Currently, Or Manifesting Bleeding Tendency 13. Any Conditions That May Confound Trial Outcomes, Prevent Subjects From Completing The Whole Trial, Including Abnormal Medical History, Untreated Diseases, Clinically Significant Abnormal Laboratory Parameters; Or Any Other Conditions Judged By The Investigator To Be Inappropriate For Participation With Potential Safety Risks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Countries
China
Contacts
Public ContactHaiquan Chen
Fudan University Shanghai Cancer Center
Outcome results
None listed