NCT06448572

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

EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	EXL01	1 capsule / day

Timeline

• Start date: 2024-07-16
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2024-06-07
• Last updated: 2025-09-25

Locations

1 site across 1 country: France