EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.

As treatment options are limited following progression on anti PD-(L)1 and platinum-based chemotherapy, we propose this trial for patients who have failed to respond or have shown intolerance to standard therapies or for whom no appropriate therapies are known to provide clinical benefit. Considering the strong therapeutic rationale of an association between antineoplastic immunotherapy and EXL01 (single-strain of F. prausnitzii, a bacteria which is a dominant member of the healthy gut microbiota), we propose to assess this combination for NSCLC treatment. This is a pilot, Phase I/II, one-arm, monocentric study evaluating the combination of EXL01 with nivolumab treatment for Non-Small Cell Lung Cancer patients.

NCT Number	NCT06448572
Lead Sponsor	University Hospital, Lille Collaborators: Exeliom Biosciences
Conditions	Non-Small Cell Lung Cancer
Enrollment	21 participants
Start Date	2024-07-16
Primary Completion	2028-10-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-25