Non-small-cell lung cancer
Conditions
Interventions
Treatment group:Two to four cycles of platinum-based doublet chemotherapy were received 4-6 weeks after surgery (non-squamous cell carcinoma: platinum + pemetrexed
Squamous cell carcinoma: Platinum + taxotaxine/gemcitabine) followed by vebreltinib (200mg bid po) until disease recurrence or intolerable toxicity, or other conditions specified in the protocol requi
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed an informed consent form. 2. Patients aged =18. 3. Histologically or cytologically confirmed NSCLC, the postoperative pathology showed stage IB-IIIB (N2). 4. Radical resection was performed, and complete resection (a negative surgical margin, R0) must be confirmed in the pathology report. 5. Have not received any anti-tumor systemic treatment before radical resection. 6. The expected survival is more than 12 weeks. 7. An Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0–1. 8. Patients must harbor METex 14 skipping mutation(NGS reports from tissue/blood samples must be approved by organizations with CLIA or CAP certification ), with or without MET amplification/ MET protein overexpression. 9. Normal lung function, withstand surgery. 10. Adequate organ and bone marrow function, defined as: a) blood routine: Absolute neutrophil count = 1.5 x10^9/L; platelet count > 100 x10^9/L; Hemoglobin = 9.0 g/dL. b) hepatic function: total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN);For patients with HCC, liver metastasis, or a history of Gilbert syndrome/suspected Gilbert syndrome (persistent or recurrent hyperbilirubinemia, primarily unbound high bilirubin, with no evidence of hemolysis or liver disease) , TBIL=3×ULN; For patients without HCC or liver metastasis, alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 × ULN; c) renal function: Serum Creatinine(Cr) = 1.5 × ULN or Creatinine Clearance (CCr)= 50 mL /min; The urine test paper showed that urine protein <2+ d) Coagulation function: Activated partial thromboplastin time (APTT) and international standardized ratio (INR) =1.5×ULN. e) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; f) Myocardial enzyme profiles were within the normal range (laboratory abnormalities not clinically significant were also allowed to be enrolled); 11. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as having been postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy. 12. If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. Patients with EGFR/ALK/ROS1 or other mutations besides MET. 2. Receive live attenuated vaccine within 4 weeks prior to enrollment or during the study period. 3. All participants should undergo brain imaging (MRI brain or CT brain contrast) prior to enrollment to rule out brain metastases. 4. Major surgery (such as intrathoracic, abdominal, or pelvic surgery) was performed within 4 weeks prior to the start of the study treatment, or the side effects of such surgery have not yet recovered. 5. Malignant diseases diagnosed other than NSCLC (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection, including papillary thyroid carcinoma after radical resection) within 5 years prior to study initiation. 6. received MET inhibitor treatment. 7. An active, known, or suspected autoimmune disease. 8. History of primary immunodeficiency. 9. History of allogeneic organ transplantation allogeneic hematopoietic stem cell transplantation. 10. Allergic to active ingredients or excipients allergic of vebreltinib, pemetrexed, gemcitabine, carboplatin, cisplatin and so on. 11. Have not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss). 12. Untreated active hepatitis B (defined as HBsAg positive combined with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center). Note: Hepatitis B subjects who meet the following criteria can also be enrolled: a) HBV viral load 140 mmHg, diastolic > 90 mmHg); e) A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to initial administration, or a current clinically active interstitial lung disease; f) active tuberculosis; g) There is an active or uncontrolled infection that requires systemic treatment; h) Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; i) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; j) Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); k) Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0 g; l) Patients with mental disorders who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year disease-free rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free time;3 year disease-free rate;3 year survival rate;overall survival;Life quality evaluation;1 year disease-free rate of the central nervous system;3 year disease-free rate of the central nervous system; | — |
Countries
China
Contacts
Public ContactJian Hu
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed