Recruiting nowPhase 3Randomised
| Registry number | NCT06662786 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 1,000 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Janssen Research & Development, LLC |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological Amivantamab
- Biological Cetuximab
- Drug 5-fluorouracil
- Drug Leucovorin calcium/Levoleucovorin
- Drug Oxaliplatin
- Drug Irinotecan Hydrochloride
What it is measuring
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
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 are testing whether amivantamab, an antibody that blocks signalling through EGFR and MET growth pathways, works better with standard chemotherapy (mFOLFOX6 or FOLFIRI) than cetuximab, the usual EGFR-blocking antibody, in untreated advanced left-sided colorectal cancer. Participants are randomly assigned to one of these treatment approaches.
The comparison asks whether amivantamab plus chemotherapy can keep the cancer from growing for longer than cetuximab plus chemotherapy. The main measure is progression-free survival, assessed by an independent review rather than overall survival.
Worth knowing: This trial is limited to unresectable or metastatic left-sided colorectal cancers that are KRAS- and NRAS-wild-type and BRAF-wild-type; it does not apply to tumours with mutations in those genes.
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
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- 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
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted.
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 238 sites. Listed in: Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), 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 NCT06662786, registered by Janssen Research & Development, LLC 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.