NCT07339839Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT07339839
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 1 Mar 2026 to the primary completion date, 30 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior PD-1/PD-L1 inhibitors or KRAS inhibitors.
- Systemic immunosuppressive therapy within 14 days prior to first dose.
- Live vaccines within 4 weeks.
- Unable to swallow oral medication.
Other illness
- History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ)
- Known hypersensitivity to study drugs.
- Active autoimmune disease or autoimmune disease history requiring systemic therapy.
- 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.
- Substance abuse, alcoholism, or psychiatric disorders impairing compliance.
- Any condition that may interfere with study participation or interpretation as judged by investigator.
Lab values
- Other actionable drivers (EGFR, ALK, ROS1, RET, BRAF, NTRK, MET, etc.).
Other
- Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma.
- Symptomatic ascites/pleural effusion needing recurrent drainage.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.