This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).
Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.
The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.
The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.
The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.
Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.
Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression \< 1% and high c-MET expression that has not received systemic treatment.