NCT07339839

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage IV
• KRAS G12C

Interventions

Type	Name	Description
DRUG	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.
DRUG	Ivonescimab	Administered intravenously at 20 mg/kg, every 3 weeks (Q3W).

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-30
• Completion: 2029-09-30
• First posted: 2026-01-14
• Last updated: 2026-01-14