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

Study acronym: EXLIBRIS
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2024 to Jul 16, 2024
    v3
  3. Primary and study completion dates: Dec 1, 2028 to Oct 1, 2028
    • Start date: Sep 1, 2024 to Jul 1, 2024
    • Eligibility criteria expanded, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06448572
Lead Sponsor University Hospital, Lille
Collaborators: Exeliom Biosciences
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov