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RECRUITING Phase 3

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

NCT06750094 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • BIOLOGICAL Cetuximab
  • BIOLOGICAL Amivantamab
  • BIOLOGICAL Bevacizumab
  • 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
  • Mount Sinai Medical Center Campus — Miami Beach
  • AdventHealth Cancer Institute — Orlando
  • Florida Cancer Specialists North Region — St. Petersburg
  • Florida Cancer Specialists East — West Palm Beach

Arizona

  • Ironwood Cancer and Research Center — Chandler
  • Banner MD Anderson Cancer Center — Gilbert
  • Arizona Oncology Associates PC NAHOA — Prescott

Arkansas

  • St. Bernard's Medical Center — Jonesboro
  • Highlands Oncology Group — Springdale

Colorado

  • University of Colorado Denver Anschultz Medical Campus — Aurora
  • Rocky Mountain Cancer Centers — Denver

Connecticut

  • Eastern Connecticut Hematology & Oncology Assoc. — Norwich

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2024-12-12
Est. Completion 2029-04-13
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06750094

The ClinicalTrials.gov registry entry for NCT06750094 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06750094 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06750094 about?

NCT06750094 is a clinical study titled "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". 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 levoleucovor...

What is the current status of trial NCT06750094?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2024-12-12. Estimated completion is 2029-04-13.

What conditions does trial NCT06750094 study?

This clinical trial studies the following conditions: Colorectal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06750094?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Amivantamab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), 5-fluorouracil (DRUG), Leucovorin calcium/Levoleucovorin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06750094?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06750094 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial