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

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

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

DRUG

MaaT033 capsule

MaaT033 capsule will be taken orally once a day for a week before every Cemiplimab cycle for the first 6 months of treatment.

DRUG

Cemiplimab

CB will be administered 350 mg IV over 30 minutes every 21 days up to 2 years

DRUG

Cisplatin

75mg/m2 at day 1 (d1) every 21 days (q21)

DRUG

Carboplatine

Area Under the Curve (AUC) 5-6 at d1 q21

DRUG

Pemetrexed (Alimta)

500mg/m2 at day 1 (d1) q21

DRUG

Bevacizumab

10mg/kg at d1 and day 15 (d15) every 28 days (q28)

DRUG

Paclitaxel

175mg/m2 at d1 q21 or 80 mg/m2 at d1, day 8 (d8), day 15 q28

DRUG

gemcitabine

1250 or 1000 mg/m2 d1, d8 q21

DRUG

Docetaxel

75 mg/m2 d1 q21 or 33mg/mq d1, d8 q21 q21

DRUG

Vinorelbine i.v. 25 mg/m²

25-30 mg/m2 d1, d8 q21

DRUG

Vinorelbine oral

30 mg/50 mg per os 3 days per week (metronomic)

Sponsors & Collaborators

• MaaT Pharma

  collaborator INDUSTRY

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Gustave Roussy, Cancer Campus, Grand Paris

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-17

Primary Completion

2030-09-30

Completion

2032-09-30

Countries

• France

Study Locations