Trials / Recruiting
RecruitingNCT06750094
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Amivantamab | Amivantamab will be administered. |
| BIOLOGICAL | Cetuximab | Cetuximab will be administered. |
| BIOLOGICAL | Bevacizumab | Bevacizumab will be administered. |
| DRUG | 5-fluorouracil | 5-fluorouracil will be administered as chemotherapy regimen. |
| DRUG | Leucovorin calcium/Levoleucovorin | Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. |
| DRUG | Irinotecan | Irinotecan will be administered as chemotherapy regimen. |
Timeline
- Start date
- 2024-12-12
- Primary completion
- 2027-12-15
- Completion
- 2029-04-13
- First posted
- 2024-12-27
- Last updated
- 2026-04-13
Locations
234 sites across 26 countries: United States, Australia, Belgium, Brazil, China, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06750094. Inclusion in this directory is not an endorsement.