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NCT06750094 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Colorectal Neoplasms, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 3
Development phase
700
Enrollment target
20
Study locations

NCT06750094 is a Phase 3 study of Colorectal Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 700 participants, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT06750094, a Phase 3 study of Colorectal Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 3
Development phase
700 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) 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

593 total trials

What the Registry Record Tells You About NCT06750094

The ClinicalTrials.gov registry entry for NCT06750094 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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.

NCT06750094 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

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.

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).

Who is sponsoring clinical trial NCT06750094?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.