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Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
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.
Official title: Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Multi-center, Phase I/II Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-03-01
Completion Date
2029-09-30
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
Glecirasib
For Phase I Dose Escalation, Glecirasib includes 2 dose cohorts: 600 mg QD and 800 mg QD, respectively, to determine the Glecirasib PR2D dose for the Phase II study.
Ivonescimab
Administered intravenously at 20 mg/kg, every 3 weeks (Q3W).