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, 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