Actively Recruiting
EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.
Led by University Hospital, Lille · Updated on 2025-09-25
21
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
E
Exeliom Biosciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- ECOG Performance Status 0-1
- Histologically or cytologically confirmed inoperable advanced or metastatic NSCLC
- No alterations in key driver oncogenes except KRAS mutations allowed
- Previous treatment with anti-PD-(L)1 agent and platinum-based chemotherapy, last dose over 15 days before study drug
- Disease progression within 6 months after first anti-PD-(L)1 dose
- Received all validated standard therapies
- Measurable disease by iRECIST 1.1
- Adequate blood counts and organ function within 72 hours before first study dose, including neutrophils, platelets, hemoglobin, creatinine clearance, bilirubin, AST and ALT within specified limits
You will not qualify if you...
- Small cell lung cancer or mixed tumors with small cell component
- Symptomatic brain metastases or carcinomatous meningitis
- Immunodeficiency or systemic corticosteroids >10 mg prednisone daily within 14 days prior to immunotherapy start
- Live attenuated vaccine within 30 days prior
- Fecal Microbiota Transplantation within 3 months prior to screening
- Serious uncontrolled heart or vascular conditions or recent stroke
- History of severe immune-mediated toxicity (grade 3 or higher) from immunotherapy
- History or current pneumonitis or interstitial lung disease requiring steroids
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Lille
Lille, France, 59000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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