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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2IMMUNOLIFE2NCT07001618

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

A Phase 2 study testing MaaT033 capsule, Cemiplimab and Cisplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Gustave Roussy, Cancer Campus, Grand Paris at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MaaT033 capsule, Cemiplimab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
6 sitesFrance
Study dates
17 Nov 2025to Sep 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation.
  • Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).
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  • Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI.
  • There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received.
  • A male participant must abstain from heterosexual activity or must agree to use a contraception as detailed below (or in Appendix 2 of this protocol) during the treatment period and for at least 9 months after the last dose of CB or BIC and refrain from donating sperm during this period. (In application of the new recommendations of the CTFG)
  • A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and if at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 2.
  • A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A WOCBP must agree to follow the contraceptive guidance in Appendix 2 or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment.
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be affiliated to a social security system or beneficiary of the same
  • Have an estimated life expectancy greater than 3 months (from inclusion).
  • Meet acceptable steroid dose thresholds (i.e., not above the acceptable threshold <10 mg prednisone daily or equivalent) if receiving systemic steroids at physiologic doses
  • Have measurable disease based on RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have adequate organ function as defined in the Table 1. All screening laboratory tests must be performed within 28 days prior to the start of study treatment.

Who cannot join

  • 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.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent and that all study drug-related AEs have resolved to grade 1 or less.
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  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Has a known history of Hepatitis B virus (HBV, defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV, considered active if HCV RNA is detected) infection. Note: no testing for HBV and HCV is required unless mandated by local health authority.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Any condition which, in the Investigator's opinion, makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol.
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of treatment.
  • Persistent toxicities related to prior treatment of grade greater than 1.
  • Swallowing disorders which can affect the intake of the oral pooled fecal microbiotherapy (MaaT033).

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa De Rosa, MD, PhD contact

+33 (0)1 42 11 24 51

Lisa.derosa@gustaveroussy.fr

Maia CLAVEAU contact

+33 (0)1 42 11 53 49

maia.Claveau@gustaveroussy.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Coureche- Guillaume KADHERBAI, MD, +33 3 80 73 75 00, cgkarderbhai@cgfl.fr

    Not yet recruiting

  • CHU Grenoble

    Grenoble, 38043

    Denis MOROS-SIBILOT, MD, +33 4 76 76 75 75, dmoro-sibilot@chu-grenoble.fr

    Not yet recruiting

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

    Gérard ZALCMAN, MD, PhD, +33 1 40 25 80 80, gerard.zalcman@aphp.fr

    Not yet recruiting

  • Hôpital Foch

    Suresnes, 92150

    Marie MAYENGA, MD, +33 1 46 25 20 00, m.mayenga@hopital-foch.com

    Recruiting

  • Centre Hospitalier Sainte Musse Toulon

    Toulon, 83000

    Clarisse AUDIGIER-VALETTE, MD, +33 4 94 14 56 10, clarisse.audigier-valette@ch-toulon.fr

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Lisa DE ROSA, MD, PhD, +33 (0)1 42 11 24 51, lisa.derosa@gustaveroussy.com

    Maia CLAVEAU, +33 (0)1 42 11 53 49, maia.Claveau@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: A Randomized Multicenter Phase II Trial Evaluating Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab (CB) Versus Best Investigator's Choice (BIC) in Resistance to PD-1/PD-L1 Blockade Due to Antibiotics (ATB) Uptake in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

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.

Read more

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
Read the 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.

Being tested
MaaT033 capsule, Cemiplimab, Cisplatin, Carboplatine, Pemetrexed (Alimta)
Keywords
MAAT033, ORAL POOLED FECAL MICROBIOTHERAPY, ADVANCED NON SMALL CELL LUNG CANCER, ANTIBIOTICS INDUCED RESISTANCE
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaaT033 capsuleDrug

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

  • CemiplimabDrug

    Also called LIBTAYO

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

  • CisplatinDrug

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

  • CarboplatineDrug

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

  • Pemetrexed (Alimta)Drug

    500mg/m2 at day 1 (d1) q21

  • BevacizumabDrug

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

  • PaclitaxelDrug

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

  • gemcitabineDrug

    1250 or 1000 mg/m2 d1, d8 q21

  • DocetaxelDrug

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

  • Vinorelbine i.v. 25 mg/m²Drug

    25-30 mg/m2 d1, d8 q21

  • Vinorelbine oralDrug

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

Study groups in NCT07001618
Study groupRoleWhat they receive
Combination of MaaT033 + Cemiplimab (CB)ExperimentalCB will be administered every 3 weeks. Oral pooled fecal microbiotherapy MaaT033 will be taken by patient (capsules) for a week before CB administration, repeated every other 3 weeks for 6 months.
Receives: Drug: MaaT033 capsule; Drug: Cemiplimab
Best Investigator's Choice (BIC)Active comparatorPatients will receive chemotherapy according to current standard of care protocols according to investigator's best choice from current guidelines combinations.
Receives: Drug: Cisplatin; Drug: Carboplatine; Drug: Pemetrexed (Alimta); Drug: Bevacizumab; Drug: Paclitaxel; Drug: gemcitabine; Drug: Docetaxel; Drug: Vinorelbine i.v. 25 mg/m²; Drug: Vinorelbine oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 12 weeks and confirmation 4-8 weeks from the initial response assessment.

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: At 12 months, 24 months, 36 months and 60 months.

  5. Incidence of AEs

    Incidence of AEs will be summarized using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0. Safety parameters include all SAEs or non-serious adverse events (AEs) and deaths graded using the NCI-CTCAE v5.0 (Common Terminology Criteria for AEs).

    Measured: At end of study, 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start17 Nov 2025
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001618
Sponsor's protocol ID
2024-517018-14-00
Other IDs
2024/3967
Acronym
IMMUNOLIFE2
Status last verified
Jul 2025
First submitted
23 May 2025
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MaaT033 capsule, Cemiplimab and Cisplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Gustave Roussy, Cancer Campus, Grand Paris at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa De Rosa, MD, PhD (+33 (0)1 42 11 24 51, Lisa.derosa@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: At 12 weeks and confirmation 4-8 weeks from the initial response assessment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07001618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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