Active — Not RecruitingPhase 3

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

United States461 participantsStarted 2021-07-19

Plain-language summary

Study CA239-0006 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Overall Survival (OS)

Timeframe: 30 months

Progression-free Survival (PFS)

Timeframe: 30 months

Trial details

NCT IDNCT04793958

SponsorMirati Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-16

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