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Not yet recruiting NCT07339839

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

Phase I / Phase II Interventional NSCLC Stage IV KRAS G12C

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glecirasib, Ivonescimab.
Who it may be relevant to
Registry conditions: NSCLC Stage IV, KRAS G12C. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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).

Primary outcome measures

  • Phase I: Maximum Tolerated Dose (MTD) [Time frame: 21 days after the first dose.]
  • Phase I: Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: 21 days after the first dose.]
  • Phase I: Recommended Phase 2 Dose (RP2D) [Time frame: 21 days after the first dose.]
  • Phase II: Objective Response Rate (ORR) [Time frame: Assessed up to 24 months]
Secondary outcome measures (5)
  • Disease Control Rate (DCR) [Time frame: Up to 24 months]
  • Progression-Free Survival (PFS) [Time frame: Up to 24 months]
  • Duration of Response (DOR) [Time frame: Up to 24 months]
  • Overall Survival (OS) [Time frame: Up to 24 months]
  • Incidence of Adverse Events (AEs) [Time frame: From first dose enrollment through 28 days after the last dose.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07339839 · NCC5886

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗