drugset

drugset / Trial / NCT04951583

Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma

NCT04951583 ↗

Phase 2 Active not recruiting 45 enrolled University of Montreal Hospital Centre (CHUM)

NaSingle-groupOpen-labelTreatment

Summary

The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy.

Timeline

Start: 2021-11-16
Primary completion: 2024-09-01
Completion: 2025-09-01

Publications

Duttagupta S, Messaoudene M, Hunter S, Desilets A, Jamal R, Mihalcioiu C, Belkaid W, Marcoux N, Fidelle M, Suissa D, Ponce M, Geiger M, Malo J, Piccinno G, Puncochar M, Filin A, Heidrich V, Rusu D, Mbaye B, Durand S, Ben Aissa I, Puller V, de Lahondes R, Blais N, Tehfe M, Owen S, Belanger K, Parvathy SN, Shieh B, Raphael J, Lenehan J, Breadner D, Rothenstein J, Rozza N, Maillou J, Nili S, Prifti DK, Pinto F, Armanini F, Kim-Schulze S, Marron TU, Kroemer G, Derosa L, Zitvogel L, Silverman M, Segata N, Maleki Vareki S, Routy B, Elkrief A. Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. Nat Med. 2026 Apr;32(4):1337-1350. doi: 10.1038/s41591-025-04186-5. Epub 2026 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fecal microbial transplantation	Unknown	—	Oral
Background	Ipilimumab	Monoclonal antibody	3 mg/kg	—
Background	Nivolumab	Monoclonal antibody	3 mg/kg	—
Background	Nivolumab	Monoclonal antibody	6 mg/kg	—
Background	Nivolumab	Monoclonal antibody	240 mg	—
Background	Nivolumab	Monoclonal antibody	480 mg	—
Background	Pembrolizumab	Monoclonal antibody	2 mg/kg	—
Background	Pembrolizumab	Monoclonal antibody	200 mg	—

Indications