NCT06252649phase 3recruiting

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

Amgen

ClinicalTrials.gov

450

Enrollment · estimated

Countries · 291 sites

2028-09

Primary completion

6 days ago

Record updated

Commercial relevance

Trial record references central lab testing referenced.

Central lab testing

Biomarker requirement language

Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.

Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial

New trial
55/100
Opportunity
New phase 3 trial NCT06252649 posted by Amgen: "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".
ClinicalTrials.gov record updated 5 days ago.

Eligibility — raw, for validation

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