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
Summary
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
Timeline
- Start
- 2025-11-17
- Primary completion
- 2030-09
- Completion
- 2032-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 10 mg/kg | — |
| Comparator | Carboplatin | Small molecule | — | — |
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 33 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | — |
| Subject | MaaT033 | Other / unclassified | — | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 30 mg | Oral |
| Comparator | Vinorelbine | Small molecule | 50 mg | Oral |