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NOT YET RECRUITING
NCT07339839
PHASE1/PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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

Interventions

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).