RightFit
RecruitingPhase 3

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

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with colorectal cancer that has spread, has a gene change called KRAS p.G12C, and has not yet been treated. It compares sotorasib, panitumumab, and FOLFIRI chemotherapy with FOLFIRI alone or with bevacizumab-awwb. Researchers will check how long people live without their cancer getting worse.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have colorectal adenocarcinoma, a cancer of the colon or rectum, that has spread and is confirmed by lab testing.
  • Have the KRAS p.G12C gene change confirmed by both a local test and the study's central lab.
  • Have cancer that has spread and can be measured using the study's rules.
  • Be able to do all usual activities or have limits only with hard physical activity.
  • Have organs that work well enough for the study.

Who can't join

  • Have active cancer that has spread to the brain and has not been treated.
  • Have cancer in the tissue and fluid around the brain and spinal cord.
  • Have already received a drug that blocks KRAS p.G12C.
  • Have a history of lung inflammation called interstitial pneumonitis or lung scarring called pulmonary fibrosis, or signs of either on the CT scan before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (26)

AZ

CA

CT

FL

GA

IL

KY

MI

MO

NC

NJ

PA

SC

TN