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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

ConditionNSCLC (Advanced Non-small Cell Lung Cancer)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

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 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who are at least 18 years of age on the day of signing informed consent,

All participants must understand spoken and written national language,

Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)

Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.

Disqualifiers

Immunodeficiency or systemic steroid therapy equivalent to prednisolone >10mg/day or equivalent within 7 days prior to the first dose of trial treatment.

Active ongoing infection requiring ATB treatment.

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MaaT033 capsule

    Drug

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

  • Cemiplimab

    Drug

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

  • Cisplatin

    Drug

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

  • Carboplatine

    Drug

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

  • Pemetrexed (Alimta)

    Drug

    500mg/m2 at day 1 (d1) q21

  • Bevacizumab

    Drug

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

  • Paclitaxel

    Drug

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

  • gemcitabine

    Drug

    1250 or 1000 mg/m2 d1, d8 q21

  • Docetaxel

    Drug

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

  • Vinorelbine i.v. 25 mg/m²

    Drug

    25-30 mg/m2 d1, d8 q21

  • Vinorelbine oral

    Drug

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

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Combination of MaaT033 + Cemiplimab (CB)Experimental treatment 2 interventions
Group B: Best Investigator's Choice (BIC)Active comparator 9 interventions

Trial outcomes

Primary outcomes

1

Disease Control Rate (DCR)

Percentage of patients who have not shown disease progression regarding complete response, partial response, stable disease as per RECIST 1.1 criteria. Confirmation of response must be demonstrated with an assessment 4-8 weeks from the initial response assessment.

Time frame
At 12 weeks and confirmation 4-8 weeks from the initial response assessment.

Secondary outcomes

1

Objective Response Rate (ORR)

Percentage of patients who have not shown disease progression regarding complete response and partial response as per RECIST 1.1 criteria.

Time frame
At 12 months, 24 months, 36 months and 60 months.
2

Progression free survival (PFS)

The PFS is defined as the time from random assignment to the progression, or death due to any cause, whichever occurs first.

Time frame
At 12 months, 24 months, 36 months and 60 months.
3

Overall survival (OS)

The OS is defined as the time from random assignment to the date of death due to any cause, or to the date of censoring at the last time the subject was known to be alive.

Time frame
At 12 months, 24 months, 36 months and 60 months.
4

Duration of response

The DoR is defined as the time from the first confirmed patient response (CR or PR) to disease progression (or death from any cause).

Time frame
At 12 months, 24 months, 36 months and 60 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

MaaT Pharma

Collaborator

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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