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

Recruiting Phase 2 Interventional Study
NSCLC (Advanced Non-small Cell Lung Cancer)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial
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 fec…
Trial Locations
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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…
Contacts

Lisa De Rosa, MD, PhD

+33 (0)1 42 11 24 51

Lisa.derosa@gustaveroussy.fr

CONTACT

Maia CLAVEAU

+33 (0)1 42 11 53 49

maia.Claveau@gustaveroussy.fr

CONTACT