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NCT06662786 · ClinicalTrials.gov registry record · Phase 3
A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
A Phase 3 study of Colorectal Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT06662786: Recruiting Phase 3 study of Colorectal Neoplasms, sponsored by Janssen Research & Development.
NCT06662786 is a Phase 3 study of Colorectal Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 1,000 participants, above the 558-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06662786, a Phase 3 study of Colorectal Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Oxaliplatin
- BIOLOGICAL Amivantamab
- DRUG 5-fluorouracil
- DRUG Leucovorin calcium/Levoleucovorin
Study Locations (20)
California
- CBCC Global Research - Bakersfield
- Los Angeles Cancer Network - Glendale
- Cancer and Blood Specialty Clinic - Los Alamitos
- USC Norris Comprehensive Cancer Center - Los Angeles
- UCLA - Santa Monica
- Providence Medical Foundation - Santa Rosa
- Torrance Memorial Physicians Network - Torrance
Florida
- Florida Cancer Specialists South - Fort Myers
- AdventHealth Medical Group Oncology and Hematology at Orlando - Orlando
- Florida Cancer Specialists North Region - St. Petersburg
- Florida Cancer Specialists East - West Palm Beach
Arkansas
- St. Bernard's Medical Center - Jonesboro
- Highlands Oncology Group - Springdale
Georgia
- Grady Memorial Hospital - Atlanta
- Winship Cancer Institute Emory University - Atlanta
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Colorado
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Yale University School Of Medicine - New Haven
District of Columbia
- Georgetown Univ Medical Center Lombardi Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2032-01-30 |
| Phase | Phase 3 |
What NCT06662786 shows while recruiting
NCT06662786 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 558-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT06662786 names 20 study sites across 9 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06662786 about?
NCT06662786 is a clinical study titled "A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer". 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 (folini...
What is the current status of trial NCT06662786?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2024-10-18. Estimated completion is 2032-01-30.
What conditions does trial NCT06662786 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT06662786?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Oxaliplatin (DRUG), Amivantamab (BIOLOGICAL), 5-fluorouracil (DRUG), Leucovorin calcium/Levoleucovorin (DRUG).
Who is sponsoring clinical trial NCT06662786?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06662786 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06662786's enrollment target sits among peer trials
1,000 5th of 54 higher than 50 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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