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OncoMatch/Clinical Trials/NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Is NCT04613596 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for advanced non-small cell lung cancer.

Phase 2/3RecruitingMirati Therapeutics Inc.NCT04613596Data as of May 2026

Treatment: Adagrasib · Adagrasib · Adagrasib · Adagrasib · Pembrolizumab — The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: KRAS G12C

KRAS G12C mutation

Required: PD-L1 (CD274) any tested (any PD-L1 TPS)

any PD-L1 TPS

Required: PD-L1 (CD274) any tested (PD-L1 TPS >=50%)

PD-L1 TPS >=50%

Disease stage

Metastatic disease required

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 007-556-A · Goodyear, Arizona
  • USOR - Arizona Oncology - Prescott Valley · Prescott Valley, Arizona
  • Local Institution - 007-568-A · Safford, Arizona
  • Local Institution - 007-568-B · Safford, Arizona
  • Local Institution - 007-568-C · Safford, Arizona

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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