Actively Recruiting
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
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-04-03
162
Participants Needed
6
Research Sites
354 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
M
MaaT Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at consent
- Must understand spoken and written national language
- Histologically confirmed NSCLC diagnosis
- Have metastatic or unresectable NSCLC and be recommended for new immunotherapy
- ECOG performance status of 0 to 2 within 7 days before treatment
- Progressed after immunotherapy or immunotherapy plus platinum chemotherapy
- Received antibiotics within 60 days before and 42 days after first immunotherapy
- Progressed within 6 months after first immunotherapy
- No limit on number of previous treatment lines
- Male participants must use contraception or abstain from heterosexual activity during treatment and 9 months after
- Female participants must not be pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test and use contraception or abstain during treatment and 180 days after
- Able and willing to comply with study visits and procedures
- Affiliated with a social security system
- Life expectancy over 3 months
- Acceptable steroid dose (less than 10 mg prednisone daily or equivalent)
- Measurable disease based on RECIST 1.1 criteria
- Adequate organ function from labs within 28 days before treatment
You will not qualify if you...
- Immunodeficiency or systemic steroid therapy above 10 mg prednisone daily within 7 days before treatment
- Active infection requiring antibiotics
- Progressing additional malignancy or recent active treatment for other cancers within 3 years
- Radiotherapy within 2 weeks before treatment start without full recovery
- Live vaccine within 30 days before first dose
- Participation in another investigational study within 4 weeks before treatment
- Active brain metastases or carcinomatous meningitis without stability
- Active autoimmune disease requiring systemic treatment in past 2 years
- Known HIV infection
- Known active Hepatitis B or C infection
- Any condition that would interfere with study participation or safety per investigator's opinion
- Patient under guardianship or unable to consent
- Pregnant, breastfeeding, or planning pregnancy during study and 180 days after
- Persistent treatment-related toxicities above grade 1
- Swallowing disorders affecting oral microbiotherapy intake
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Centre Georges François Leclerc
Dijon, France, 21079
Not Yet Recruiting
2
CHU Grenoble
Grenoble, France, 38043
Not Yet Recruiting
3
Hôpital Bichat - Claude Bernard
Paris, France, 75018
Not Yet Recruiting
4
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
5
Centre Hospitalier Sainte Musse Toulon
Toulon, France, 83000
Actively Recruiting
6
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
L
Lisa De Rosa, MD, PhD
CONTACT
M
Maia CLAVEAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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