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Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Status
Active
Cancer Type
Colon/Rectal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06252649
Protocol IDs
20210081 (primary)
NCI-2024-03471
Study Sponsor
Amgen, Inc.

Summary

The aim of this study is to compare progression free survival (PFS) in treatment-naïve
Participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving
sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Eligibility

  1. Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  2. Central confirmation of KRAS p.G12C mutation
  3. Measurable metastatic disease per RECIST v1.1 criteria.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1.
  5. Adequate organ function.

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.