Combining EXL01 with Nivolumab for Advanced Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the combination of EXL01, a single-strain bacterium from the healthy gut microbiota, with nivolumab, an immunotherapy drug, for patients with advanced non-small cell lung cancer (NSCLC) who have not responded to standard treatments. It is a pilot Phase I/II, one-arm, monocentric study aimed at evaluating the safety and efficacy of this combination therapy. The study targets patients who have progressed after receiving anti-PD-(L)1 agents and platinum-based chemotherapy, focusing on those with limited treatment options. The goal is to assess whether this novel combination can provide clinical benefit in a challenging patient population.

Why it matters

Who can join: the full rules

Key inclusion Criteria:

1. Patients (male or female) ≥18 years old.
2. ECOG Performance status (PS) 0-1 (WHO).
3. Histologically or cytologically documented inoperable advanced/metastatic NSCLC. (inoperable stage III not amenable to radiation therapy or surgery, stage IV)
4. No alterations of key driver oncogenes including EGFR (mutations), ALK (fusions), ROS1 (fusions), MET (METex14 mutations), HER2 (exon 20 insertions), RET (fusions), or BRAF (V600E mutations). KRAS mutations are allowed.
5. Must have previously received anti-PD(L)1 agent and platinum-based chemotherapy, either concomitantly or sequentially. Last dose to have been administered more than 15 days prior to first dose of study drug.
6. Must have progressed within 6 months after first dose of anti-PD(L)1 given either alone or in combination with platinum-based chemotherapy.
7. Must have received all validated available standard therapies.
8. Measurable disease according to iRECIST 1.1.
9. Adequate hematological, renal and liver functions within 72 hours before the first dose of study treatment:

   * Absolute Neutrophil Count ≥ 1500/μL
   * Platelets ≥ 100 000/μL
   * Hemoglobin ≥ 9.0 g/dL
   * Creatinine Clearance ≥ 50 mL/min
   * Total Bilirubin ≤ 1.5 x ULN
   * AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastasis)

Key exclusion Criteria:

1. Small cell lung cancer or tumors with mixed histology including a SCLC component.
2. Known symptomatic CNS metastases and/or carcinomatous meningitis. Participants with asymptomatic brain metastases (ie, no neurological symptoms and no requirements for corticosteroids \> 10mg/d prednisone equivalent) may participate.
3. Diagnosis of immunodeficiency of is receiving systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the immunotherapy induction. Inhaled, nasal or topic corticosteroids are allowed.
4. Living attenuated vaccine received within the 30 previous days.
5. Has received Fecal Microbiota Transplantation within 3 months prior to Screening.
6. General serious condition such as uncontrolled congestive cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6 months), history or stroke within the 6 previous months.
7. History of severe immune-mediated toxicity (≥ grade 3) under immunotherapy treatment.
8. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Where it's running

• CHU Lille
  Lille, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.