A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

Phase 2 Completed 107 enrolled Pierre Fabre Laboratories Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Encorafenib is currently being developed (with or without binimetinib), in combination with cetuximab, for the treatment of adult patients with B-RAF proto-oncogene, serine/threonine kinase V600E mutant (BRAF V600E) metastatic colorectal cancer (mCRC), who have received prior systemic therapy.

Timeline

Start: 2021-09-14
Primary completion: 2023-12-19
Completion: 2024-12-07

Publications

Xicheng W, Yanhong D, Yanqiao Z, Tianshu L, Xianglin Y, Jianwei Y, Tao Z, Aimin Z, Yu L, Li H, Feng Y, Hong Z, Yi B, Isabelle K, Jean-Claude V, Melanie G, Angela G, Jian L, Lin S. A Randomized Trial of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or FOLFIRI/Cetuximab in Chinese Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: The NAUTICAL Study. Cancer Med. 2026 Mar;15(3):e71697. doi: 10.1002/cam4.71697.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Encorafenib	Small molecule	300 mg	Oral
Subject	Irinotecan	Small molecule	180 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	1200 mg/m2	Intravenous
Background	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous

A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

Summary

Timeline

Publications

Drugs

Indications