At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Amivantamab (biological), Cetuximab (biological), 5-fluorouracil (drug), Leucovorin calcium/Levoleucovorin (drug)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- Amivantamab — biological: Amivantamab will be administered. · Cetuximab — biological: Cetuximab will be administered. · 5-fluorouracil — drug: 5-fluorouracil will be administered as chemotherapy regimen. · Leucovorin calcium/Levoleucovorin — drug: Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. · Oxaliplatin — drug: Oxaliplatin will be administered as chemotherapy regimen. · Irinotecan Hydrochloride — drug: Irinotecan hydrochloride will be administered as chemotherapy regimen.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2024-10-18
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal neoplasms
- • Phase3 - 1,000 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal neoplasms
Where?
- • Birmingham - Birmingham Heartlands Hospital
- • Cambridge - Addenbrooke's Hospital
- • Edinburgh - Western General Hospital
- • Hull - Castle Hill Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ unresectable or metastatic disease
- ✓ concluded greater than (\>) 12 months
What the study is looking for
- ✓Have confirmed by testing a sample adenocarcinoma of the left-sided colorectal cancer. Participants must...
- ✓Must agree to the submission of fresh tumor tissue
- ✓Have cancer that can be measured on scans according to (standard scan measurements)
- ✓Have an activity scale (ECOG) performance status (PS) of 0 or 1
Who cannot take part
- ✗Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or...
- ✗Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human...
- ✗Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial...
See the full criteria
Where Is This Study? (9 UK sites)
Birmingham Heartlands Hospital
Birmingham B9 5ST, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Castle Hill Hospital
Hull HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903St James University Hospital
Leeds LS9 7TF, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
University College Hospital
London NW1 2BU, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Mount Vernon Cancer Centre
Northwood HA6 2RN, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
