Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC

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.

NCT Number	NCT07339839
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions	NSCLC Stage IV, KRAS G12C
Enrollment	42 participants
Start Date	2026-03-01
Primary Completion	2027-09-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-14