A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
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
• Voluntarily participate in the study and signed the ICF;
• Male or female, aged 18-75 years;
• 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;
• For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy;
• Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity;
• Ability to provide at least 6 sections of tumor tissue specimens for staining and testing;
• ECOG PS score 0 or 1;
• At least one measurable lesion according to RECIST v1.1 criteria;
• Expected survival ≥ 12 weeks;
⁃ Adequate bone marrow and organ function;
⁃ Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose, during which time the female subject is not breastfeeding and the male subject avoids sperm donation.