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

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

Trial Details

NCT ID
NCT07001618
Phase
PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • MaaT033 capsule
  • Cemiplimab
  • Cisplatin
  • Carboplatine
  • Pemetrexed (Alimta)
  • Bevacizumab
Locations (sample)
  • Dijon, France|47.31344,5.01391
  • Grenoble, France|45.17869,5.71479
  • Paris, France|48.85341,2.3488
  • Suresnes, France|48.87143,2.22929
  • Toulon, France|43.12442,5.92836

Key Eligibility Criteria

  • Participants who are at least 18 years of age on the day of signing informed consent,
  • All participants must understand spoken and written national language,
  • Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)
  • Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.

For full eligibility, visit ClinicalTrials.gov.

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