Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT07001618
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MaaT033 capsule — DRUG
    MaaT033 capsule will be taken orally once a day for a week before every Cemiplimab cycle for the first 6 months of treatment.
  • Cemiplimab — DRUG
    CB will be administered 350 mg IV over 30 minutes every 21 days up to 2 years
  • Cisplatin — DRUG
    75mg/m2 at day 1 (d1) every 21 days (q21)
  • Carboplatine — DRUG
    Area Under the Curve (AUC) 5-6 at d1 q21
  • Pemetrexed (Alimta) — DRUG
    500mg/m2 at day 1 (d1) q21
  • Bevacizumab — DRUG
    10mg/kg at d1 and day 15 (d15) every 28 days (q28)
  • Paclitaxel — DRUG
    175mg/m2 at d1 q21 or 80 mg/m2 at d1, day 8 (d8), day 15 q28
  • gemcitabine — DRUG
    1250 or 1000 mg/m2 d1, d8 q21
  • Docetaxel — DRUG
    75 mg/m2 d1 q21 or 33mg/mq d1, d8 q21 q21
  • Vinorelbine i.v. 25 mg/m² — DRUG
    25-30 mg/m2 d1, d8 q21
  • Vinorelbine oral — DRUG
    30 mg/50 mg per os 3 days per week (metronomic)

Study Details

The goal of IMMUNOLIFE2 is to overcome primary resistance to immune checkpoint inhibitors (ICIs), such as pembrolizumab or nivolumab used alone or in combination with chemotherapy, observed in patients with advanced non-small cell lung cancer (NSCLC) following antibiotic exposure, which induces intestinal dysbiosis. The reintroduction of immunotherapy with Cemiplimab, combined with oral pooled fecal microbiotherapy (MaaT033), aims to restore gut microbiota and potentially reverse resistance to ICIs. The main objective is to determine whether the combination of MaaT033 and Cemiplimab provides a superior disease control rate compared to the current best investigator's choice as comparator. Patients will be randomized to receive either: * Experimental arm: MaaT033 administered orally for one week prior to each cycle of Cemiplimab, which will be given in hospital care every 3 weeks for 6 months, followed by Cemiplimab alone thereafter; * Control arm: Best investigator's choice

Key Dates

Start date
Nov 17, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2030
Completion
Sep 30, 2032

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of MaaT033 + Cemiplimab (CB)
    CB will be administered every 3 weeks. Oral pooled fecal microbiotherapy MaaT033 will be taken by patient (capsules) for a week before CB administration, repeated every other 3 weeks for 6 months.
  • Active Comparator: Best Investigator's Choice (BIC)
    Patients will receive chemotherapy according to current standard of care protocols according to investigator's best choice from current guidelines combinations.

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: At 12 weeks and confirmation 4-8 weeks from the initial response assessment. ]

Central Contacts

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