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,

Trial Details

NCT ID
NCT06448572
Phase
PHASE1 / PHASE2
Sponsor
University Hospital, Lille
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • EXL01
Locations (sample)
  • Lille, France|50.63391,3.05512

Key Eligibility Criteria

  • Patients (male or female) ≥18 years old.
  • ECOG Performance status (PS) 0-1 (WHO).
  • Histologically or cytologically documented inoperable advanced/metastatic NSCLC. (inoperable stage III not amenable to radiation therapy or surgery…
  • No alterations of key driver oncogenes including EGFR (mutations), ALK (fusions), ROS1 (fusions), MET (METex14 mutations), HER2 (exon 20 insertions…

For full eligibility, visit ClinicalTrials.gov.

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