A Phase 3 interventional study of FOLFIRI Regimen and Sotorasib in Metastatic Colorectal Cancer, sponsored by Amgen. Recruiting at 291 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 450 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Drug: FOLFIRI Regimen · Drug: Sotorasib · Drug: Panitumumab
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Drug: FOLFIRI Regimen · Drug: Bevacizumab-awwb
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Immediate-release solid dosage form administered orally.
Also known as: AMG 510, Lumakras, Lumykras
Administered via IV infusion Q2W.
Also known as: Vectibix
Administered via IV infusion Q2W.
Also known as: MVASI
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
Time frame: Up to Approximately 5 Years
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Objective Response (OR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to Approximately 5 Years
Depth of Response per RECIST v1.1
Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.
Time frame: Up to Approximately 5 Years
Time to Early Tumor Shrinkage (ETS) per RECIST v1.1
Time frame: Up to Approximately 5 Years
PFS Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
ORR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
DOR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
DCR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
TTR Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
Depth of Response Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
Time to ETS Based on Investigator's Assessment per RECIST v1.1
Time frame: Up to Approximately 5 Years
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to Approximately 5 Years
Pre-dose (Ctrough) Concentrations of Sotorasib
Time frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
Maximum Plasma Concentration (Cmax) of Sotorasib
Time frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)
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Showing the first 100 of 291 sites across 35 countries. Choose a country and city above to see the rest.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Started Jul 2024 (actual). Primary completion is estimated for Sep 2028, 50 months after the start.
Of 69 industry-sponsored phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's planned 50 months is above that.
Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Sotorasib · Panitumumab