NCT07001618 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
| NCT ID | NCT07001618 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | NSCLC (Advanced Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2030-09 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Participants who are at least 18 years of age on the day of signing informed consent, 2. All participants must understand spoken and written national language, 3. Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others) 4. Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy. 5. Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation. 6. Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly). 7. Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI. 8. There are no restrictions on the number of prior lines of treatment
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.