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Clinical Trials List

Protocol Number61186372COR3002
NCT Number(ClinicalTrials.gov Identfier)NCT06750094
Active

2024-11-01 - 2029-12-31

Phase III

Not yet recruiting3

Recruiting4

ICD-10C20

Malignant neoplasm of rectum

ICD-10C7A.026

Malignant carcinoid tumor of the rectum

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9154.1

Malignant neoplasm of rectum

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

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/09

Investigators and Locations

Principal Investigator FAN -FENG CHIANG Division of Colorectal Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kun-Huei Yeh 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hao-Wei Teng Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Colorectal Neoplasms

Objectives

The objective of this trial was to compare the duration of disease-free (advanced progression-free survival) and the duration of death (overall survival) in participants receiving Amivantamab and 5-Fluorouracil chemotherapy with Leucovorin Calcium or Levoleucovorin and Irinotecan hydrochloride (FOLFIRI) compared with Cetuximab or Bevacizumab and FOLFIRI in participants with recurrent, unresectable, or metastatic colorectal cancer who had previously received chemotherapy and were oncogenes of Kirsten rat sarcoma virus oncogenes/neuroblastoma RAS virus oncogene homologs (KRAS/NRAS) and V-RAF murine sarcoma virus oncogene homolog B (BRAF) wild-type.

Test Drug

Injectable solution
Injectable preparation
Injectable preparation

Active Ingredient

1013009400
Cetuximab
1013000800

Dosage Form

279
270
270

Dosage

MG/ML

Endpoints

- Progression-free survival (PFS) assessed by a blinded, central, independent evaluation committee (BICR)

- Overall survival (OS)

Inclution Criteria

Inclusion Criteria:

Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

Exclusion Criteria

Exclusion Criteria:

Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    700 participants

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