Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT07001618
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
Detailed Description:
IMMUNOLIFE2 is a randomized Phase II clinical trial multicenter aiming at circumventing primary resistance to ICI observed in patients with advanced NSCLC following ATB uptake in the harmful window using FMT strategy (oral pooled fecal microbiotherapy MaaT033) concomitant to CB. Hence the IMMUNOLIFE2 trial described here is exploring the possibility of an improvement of DCR to CB in patients with ICI resistance due to ATB-induced gut dysbiosis. This will be an outstanding opportunity to explore a therapeutic strategy to surpass ATB mediated resistance but for any cause of intestinal dysbiosis that compromise anti-PD1-based therapy efficacy.
Study:
NCT07001618
Study Brief:
Protocol Section:
NCT07001618