A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Trial Parameters
Brief Summary
Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in the study and signed the ICF; 2. Male or female, aged 18-75 years; 3. All participants to be enrolled must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced (stage IIIB/IIIC )or recurrent metastatic NSCLC (stage IV ) and not amendable to curative surgery or radiation as assessed by investigator; 4. For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy; 5. Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity; 6. Ability to provide at least 6 sections of tumor tissue specimens for staining and testing； 7. ECOG PS score 0 or 1； 8. At least one measurable lesion according to RECIST v1.1 criteria； 9. Expected survival ≥ 12 weeks; 10. Adequate bone marrow and organ function； 11. Female subjects of childbearing potential or male subjects whose partners are of child