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

Starting soon · Phase 1/Phase 2

Conditions studied: NSCLC Stage IV, KRAS G12C

In brief

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.

Key facts

Study ID

NCT07339839

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

42

Starts

2026-03-01

Expected to finish

2029-09-30

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent.
• Age ≥18 years.
• Newly diagnosed, unresectable, locally advanced (ineligible for curative concurrent - chemoradiotherapy) or metastatic NSCLC per AJCC 9th edition.
• KRAS G12C mutation confirmed by validated testing.
• PD-L1 TPS ≥1%.
• ≥1 measurable lesion per RECIST v1.1.
• No prior systemic therapy for advanced/metastatic NSCLC; prior adjuvant therapy allowed if completed >6 months before dosing and toxicities recovered to ≤Grade 1.
• ECOG PS 0-2.
• Life expectancy >3 months
• Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds)
• Negative pregnancy test for women of childbearing potential; adequate contraception for men and women through 3 months post-treatment
• Willing and able to comply with study procedures and follow-up.

You may not qualify if…

• History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ)
• Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma.
• Other actionable drivers (EGFR, ALK, ROS1, RET, BRAF, NTRK, MET, etc.).
• Known hypersensitivity to study drugs.
• Prior PD-1/PD-L1 inhibitors or KRAS inhibitors.
• Active autoimmune disease or autoimmune disease history requiring systemic therapy.
• Systemic immunosuppressive therapy within 14 days prior to first dose.
• Symptomatic ascites/pleural effusion needing recurrent drainage.
• Significant cardiovascular disease (NYHA ≥2, MI within 1 year, uncontrolled arrhythmias).
• Active infection, unexplained fever >38.5°C.
• Interstitial lung disease or pneumonitis.
• HIV infection or other immunodeficiency.
• Live vaccines within 4 weeks.
• Substance abuse, alcoholism, or psychiatric disorders impairing compliance.
• Unable to swallow oral medication.
• Any condition that may interfere with study participation or interpretation as judged by investigator.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.