lung cancer
Conditions
Interventions
Test group: Vebreltinib (150mg bid po) plus Andamertinib (80mg qd po)
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign informed consent 2. Age >= 18 years old. 3. Locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. 4. Have c-met overexpression (overexpression IHC 50% 2++ and above) after failure of EGFR-TKI treatment. Immunohistochemical met overexpression will be detected in the hospital, and initial diagnosis or after EGFR-TKI resistance can both be aceepted. 5. Expected survival time >= 3 months. 6. According to the response evaluation criteria for solid tumors version 1.1 (RECIST v1.1), there is at least 1 measurable or evaluable lesion. 7. According to the Eastern Cooperative Oncology Group physical status score (ECOG PS score), it is 0-2 points. 8. Having adequate organ and bone marrow functions, defined as follows: a) Blood routine: absolute neutrophil count >= 1.5 × 10^9/l; platelet count >= 100 × 10^9/l; hemoglobin content >= 9.0 g/dl. b) Liver function: serum total bilirubin (TBIL) = 50ml/min; Urine test results showed that urine protein was <2+. d) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN. e) Thyroid function was normal, 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) The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the investigator are also allowed to be enrolled); 9.Female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first dose of study drug (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (whether male or female) should take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Patients with ALK/ROS1 and other sensitive mutations other than MET and EGFR. 2. Patients with MET14 exon skipping mutations. 3. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period. 4. Patients has received other systemic anti-tumor therapies in addition to EGFR-TKI. 5. Patients undergo major surgery (such as thoracic, abdominal or pelvic surgery) within 4 weeks before the start of study treatment, or the side effects of such surgery have not yet recovered. 6. With other malignant diseases other than NSCLC diagnosed within 5 years before the start of study treatment (excluding skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or carcinoma in situ after radical resection, papillary thyroid carcinoma can also be enrolled after radical resection); 7. With active, known or suspected autoimmune disease. 8. Known history of primary immunodeficiency. 9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10. Known to be allergic to the active ingredients or excipients of the study drugs vebreltinib and andamertinib. 11. Have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., <= grade 1 or reaching baseline, excluding fatigue or hair loss); 12. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression free survival rate;Duration of response;Disease control rate;Overall survival;Incidence of adverse reactions;Incidence of serious adverse events;Incidence of treatment-related adverse events ; | — |
Countries
China
Contacts
Public ContactYong Zhang
Zhongshan Hospital, Fudan University
Outcome results
None listed