/ Erasmus MC / NSCLC /
KRYSTAL
1e lijns
KRAS G12C
A Phase 2 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Stadium
IV
Mutatie
KRAS G12C
Lijn
1e lijn
Site
Erasmuc MC
Population
Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Design
Key outcome parameters
Intervention
MRTX849, pembrolizumab
Key inclusion criteria
Inclusion criteria:
- Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with
KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score. - Unresectable or metastatic disease.
- Not a candidate for definitive therapy (e.g., chemoradiation for locally advanced
disease). - PD-L1 >50%
Key exclusion criteria
Exclusion criteria:
- 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)
- Radiation to the lung >30 Gy within 6 months prior to the first dose of study treatment
- Active brain metastases. Patients are eligible if brain metastases are adequately treated and patients are neurologically stable (except for residual signs or symptoms related to the central nervous system [CNS] treatment) for at least 2 weeks prior to the first dose of study treatment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
- Carcinomatous meningitis
