Condition: NSCLC (Advanced Non-small Cell Lung Cancer) · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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
This description comes directly from the study's public registry record.
Lisa De Rosa, MD, PhD · +33 (0)1 42 11 24 51 · Lisa.derosa@gustaveroussy.fr
Maia CLAVEAU · +33 (0)1 42 11 53 49 · maia.Claveau@gustaveroussy.fr
Always discuss trial participation with your own doctor first.
| Centre Georges François Leclerc | Dijon, France | Not Yet Recruiting |
| CHU Grenoble | Grenoble, France | Not Yet Recruiting |
| Hôpital Bichat - Claude Bernard | Paris, France | Not Yet Recruiting |
| Hôpital Foch | Suresnes, France | Recruiting |
| Centre Hospitalier Sainte Musse Toulon | Toulon, France | Recruiting |
| Gustave Roussy | Villejuif, France | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07001618