This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.
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Phase I: Maximum Tolerated Dose (MTD)
Timeframe: 21 days after the first dose.
Phase I: Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: 21 days after the first dose.
Phase I: Recommended Phase 2 Dose (RP2D)
Timeframe: 21 days after the first dose.
Phase II: Objective Response Rate (ORR)
Timeframe: Assessed up to 24 months