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

Phase 1

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: EXL01

• Registration Number: NCT06448572
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Study Start: 2024-07-16
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2028-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXL01 + Nivolumab	EXL01	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate (PFS Rate) for the assessment of efficacy, defined as the rate of alive and non-progressive subjects as per iRECIST 1.1 over the study subjects.	At 3 months from the inclusion

Secondary Outcome Measures

Name	Time	Method
Number of Grade ≥ 3 treatment-related AEs, using CTCAE	First 6 weeks of treatment
Progression Free Survival, defined as the time from inclusion to the first documented disease progression or death due to any cause, whichever occurs first.	First 6 weeks of treatment
ORR (Overall Response Rate) as per iRECIST1.1 for the assessment of efficacy, defined as the rate of confirmed Complete Response (CR) or Partial Response (PR) over the study subjects efficacy responses.	First 6 weeks of treatment
Overall Survival, defined as the time from inclusion to the date of death due to any cause	First 6 weeks of treatment
Disease Control Rate, defined as the rate of confirmed Complete Response (CR), or Partial Response (PR), or Stable Disease (SD) over the study subjects efficacy responses	First 6 weeks of treatment

Trial Locations

Locations (1)

CHU Lille; 🇫🇷 Lille, France