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
NCT ID: NCT07001618
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
162 participants
INTERVENTIONAL
2025-09-30
2032-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors
NCT03169738
In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors
NCT04616248
Open-label, Uncontrolled, Non-Interventional, Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors (Anti-PD-1/Anti-PD-L1 Monoclonal Antibodies) Treatment for Solid Tumors
NCT04860076
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
NCT05078047
QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy
NCT03167177
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combination of MaaT033 + Cemiplimab (CB)
CB 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.
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.
Cemiplimab
CB will be administered 350 mg IV over 30 minutes every 21 days up to 2 years
Best Investigator's Choice (BIC)
Patients will receive chemotherapy according to current standard of care protocols according to investigator's best choice from current guidelines combinations.
Cisplatin
75mg/m2 at day 1 (d1) every 21 days (q21)
Carboplatine
Area Under the Curve (AUC) 5-6 at d1 q21
Pemetrexed (Alimta)
500mg/m2 at day 1 (d1) q21
Bevacizumab
10mg/kg at d1 and day 15 (d15) every 28 days (q28)
Paclitaxel
175mg/m2 at d1 q21 or 80 mg/m2 at d1, day 8 (d8), day 15 q28
gemcitabine
1250 or 1000 mg/m2 d1, d8 q21
Docetaxel
75 mg/m2 d1 q21 or 33mg/mq d1, d8 q21 q21
Vinorelbine i.v. 25 mg/m²
25-30 mg/m2 d1, d8 q21
Vinorelbine oral
30 mg/50 mg per os 3 days per week (metronomic)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Cemiplimab
CB will be administered 350 mg IV over 30 minutes every 21 days up to 2 years
Cisplatin
75mg/m2 at day 1 (d1) every 21 days (q21)
Carboplatine
Area Under the Curve (AUC) 5-6 at d1 q21
Pemetrexed (Alimta)
500mg/m2 at day 1 (d1) q21
Bevacizumab
10mg/kg at d1 and day 15 (d15) every 28 days (q28)
Paclitaxel
175mg/m2 at d1 q21 or 80 mg/m2 at d1, day 8 (d8), day 15 q28
gemcitabine
1250 or 1000 mg/m2 d1, d8 q21
Docetaxel
75 mg/m2 d1 q21 or 33mg/mq d1, d8 q21 q21
Vinorelbine i.v. 25 mg/m²
25-30 mg/m2 d1, d8 q21
Vinorelbine oral
30 mg/50 mg per os 3 days per week (metronomic)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.
5. 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.
6. Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).
7. 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.
8. There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received.
9. 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)
10. 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:
1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2.
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.
11. 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.
12. Patients must be affiliated to a social security system or beneficiary of the same
13. Have an estimated life expectancy greater than 3 months (from inclusion).
14. 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
15. 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.
16. 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.
Exclusion Criteria
2. Active ongoing infection requiring ATB treatment.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Has a known history of Human Immunodeficiency Virus (HIV).
10. 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.
11. 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.
12. 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.
13. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
14. 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.
15. Persistent toxicities related to prior treatment of grade greater than 1.
16. Swallowing disorders which can affect the intake of the oral pooled fecal microbiotherapy (MaaT033).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MaaT Pharma
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024/3967
Identifier Type: OTHER
Identifier Source: secondary_id
2024-517018-14-00
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.