The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC
Trial Parameters
Brief Summary
This is an open-label, single-arm, dose-escalation, multicenter phase I/II clinical trial. The primary endpoints of this study were to evaluated the safety, tolerability, pharmacokinetic profile and preliminary efficacy of HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The secondary endpoints of this study were to evaluated the efficacy HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy.
Eligibility Criteria
Inclusion Criteria: * Eligible subjects selected for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Age ≥18 years old; 3. No limit on the gender; 4. Histological or cytological confirmed advanced or metastatic non-small cell lung cancer, ineligible for radical surgery, relapse after failure of previous treatment with first-line (including first, second, and third generation)EGFR inhibitors. Cohort A：MET amplification,(by FISH, NGS or IHC) Cohort B：RET fusion. 5. Laboratory tests for organ function levels must meet the following requirements: 1. Absolute neutrophil count ≥ 1.5 × 109/L; 2. Platelet count ≥ 100 × 109/L; 3. Hemoglobin ≥ 9 g/dL; 4. Bilirubin ≤1.5 times ULN; e) AST and ALT ≤2.5 times ULN (total bilirubin ≤3 times the upper limit of normal and AST and ALT ≤5 times the upper limit of normal are permitted if hepatic metastases are present); f) Serum creatinine ≤ 1.5 times ULN or creatinin