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

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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

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06750094
Protocol IDs
61186372COR3002 (primary)
NCI-2025-00175
2024-513853-66-00
61186372COR3002
Study Sponsor
Janssen Pharmaceuticals

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.

Eligibility

  1. Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  2. 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
  3. Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
  4. Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  5. Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
  6. 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

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