Running, not taking new patientsPhase 3Randomised
| Registry number | NCT04793958 |
|---|---|
| Recruitment | Running, not taking new patients |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 461 people (final) |
| Who can join | aged 18 Years and over |
| Run by | Mirati Therapeutics Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug MRTX849
- Biological Cetuximab
- Drug mFOLFOX6 Regimen
- Drug FOLFIRI Regimen
What it is measuring
Overall Survival (OS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers think that blocking the KRAS G12C mutation with MRTX849 (adagrasib), while also blocking EGFR growth signals with cetuximab, may control advanced colorectal cancer better than chemotherapy alone. The trial tests this combination against mFOLFOX6 or FOLFIRI as second-line treatment.
The comparison is with chemotherapy that would otherwise commonly be used after an earlier treatment has stopped working. The main measure is overall survival, so an improvement would mean patients live longer, not simply that scans show the cancer is temporarily smaller or stable.
Worth knowing: This is an open-label trial, so patients and doctors know which treatment is being given, and the treatment has not yet been shown to improve survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Exclusion Criteria
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- Active brain metastasis
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 419 sites. Listed in: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04793958, registered by Mirati Therapeutics Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.