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
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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 Endpoints
Disease Control Rate (DCR)
Progression-Free Survival (PFS)
Duration of Response (DOR)
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…
Read full criteria on CT.gov →✦ Analyst Commentary
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