Trial comparing treatments for Metastatic Colorectal Cancer
Official title 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 ID: NCT06252649
What this study is testing
What is FOLFIRI Regimen?
An investigational combination chemotherapy being studied for metastatic colorectal cancer.
Also referred to as irinotecan, leucovorin, 5-fluorouracil.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how long patients stay free of cancer progression when treated with FOLFIRI plus sotorasib and panitumumab versus FOLFIRI alone or with bevacizumab.
- Who it's for
- It is looking for adults who have not yet received treatment for metastatic colorectal cancer that has a KRAS p.G12C mutation.
- What's involved
- Participants will receive chemotherapy (FOLFIRI) with either the added drugs sotorasib and panitumumab or, in some groups, bevacizumab. They will have regular clinic visits and tests to monitor the cancer and side‑effects.
- Time commitment
- The study lasts about 12 months, with frequent visits for treatment and monitoring throughout that period.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Pikeville, Kentucky, United States
- Grand Rapids, Michigan, United States
- Durham, North Carolina, United States
- Nashville, Tennessee, United States
- CABA, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Córdoba, Córdoba Province, Argentina
- Viedma, Río Negro Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Buenos Aires, Argentina
- Camperdown, New South Wales, Australia
- Toowoomba, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Bedford Park, South Australia, Australia
+ 168 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Long Beach, California, United States; Los Alamitos, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Pikeville, Kentucky, United States and 182 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.