Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Trial number:
NCT04793958
Trial phase:
3
Study type:
Targeted therapy, Biomarker
Overall status:
Recruiting

Study start date

March, 2021

Scientific title

A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy

Summary

Study 849-010 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab). Active brain metastasis

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Advanced Colorectal Cancer, Metastatic Colorectal Cancer

Other study ID numbers

849-010; KRYSTAL-10

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