NCT06252649 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
| NCT ID | NCT06252649 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2028-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2024-07-17 with a primary completion date of 2028-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection of KRAS p.G12C mutation. * Measurable metastatic disease per RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. Exclusion Criteria: * Active, untreated brain metastases. * Leptomeningeal disease * Previous treatment with a KRAS p.G12C inhibitor * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT06252649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06252649 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06252649 currently recruiting?
Yes, NCT06252649 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT06252649 trial being conducted?
This trial is being conducted at Chandler, United States, Fullerton, United States, Long Beach, United States, Los Alamitos, United States and 11 additional locations.
Who is sponsoring the NCT06252649 clinical trial?
NCT06252649 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 450 participants.
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