RecruitingPhase 1Phase 2NCT06448572

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

EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy

Sponsor

University Hospital, Lille

Enrollment

21 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of EXL01 (a new experimental drug) and nivolumab (an immunotherapy) in people with advanced non-small cell lung cancer that has already stopped responding to immunotherapy. It aims to see whether this combo can reactivate the immune response against the cancer. **You may be eligible if...** - You are 18 or older with good overall function (ECOG 0–1) - You have inoperable advanced or metastatic non-small cell lung cancer (stage III or IV) - Your tumor does not have common driver mutations (EGFR, ALK, ROS1, MET, HER2, RET, BRAF) - You have previously received immunotherapy and platinum-based chemotherapy **You may NOT be eligible if...** - Your cancer has a targetable driver mutation (unless already treated) - You have not received prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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