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MaaT033

Phase 2

NSCLC (Advanced Non-small Cell Lung Cancer) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 3, 2026

Target and mechanism

ModalitySmall molecule

Also known as MaaT033 capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

MaaT033 · 1 trial · 1 indication

Phase 2 1
NCT07001618Oral 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 CancerNSCLC (Advanced Non-small Cell Lung Cancer)
RECRUITING162 Analytics
PHASE2RECRUITING
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
NSCLC (Advanced Non-small Cell Lung Cancer)Unlock trial analytics

Study Endpoints

Primary Endpoints

Disease Control Rate (DCR)
At 12 weeks and confirmation 4-8 weeks from the initial response assessment.

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.

Secondary Endpoints

Objective Response Rate (ORR)
At 12 months, 24 months, 36 months and 60 months.
Progression free survival (PFS)
At 12 months, 24 months, 36 months and 60 months.
Overall survival (OS)
At 12 months, 24 months, 36 months and 60 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.

Interventions

NameTypeDescription
MaaT033 capsuleDRUGMaaT033 capsule will be taken orally once a day for a week before every Cemiplimab cycle for the first 6 months of treatment.
CemiplimabDRUGCB will be administered 350 mg IV over 30 minutes every 21 days up to 2 years
CisplatinDRUG75mg/m2 at day 1 (d1) every 21 days (q21)
CarboplatineDRUGArea Under the Curve (AUC) 5-6 at d1 q21
Pemetrexed (Alimta)DRUG500mg/m2 at day 1 (d1) q21
BevacizumabDRUG10mg/kg at d1 and day 15 (d15) every 28 days (q28)
PaclitaxelDRUG175mg/m2 at d1 q21 or 80 mg/m2 at d1, day 8 (d8), day 15 q28
gemcitabineDRUG1250 or 1000 mg/m2 d1, d8 q21
DocetaxelDRUG75 mg/m2 d1 q21 or 33mg/mq d1, d8 q21 q21
Vinorelbine i.v. 25 mg/m²DRUG25-30 mg/m2 d1, d8 q21
Vinorelbine oralDRUG30 mg/50 mg per os 3 days per week (metronomic)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Participants who are at least 18 years of age on the day of signing informed consent, 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...

Countries:France
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Frequently asked questions about MaaT033

What is MaaT033 used for in NSCLC?

MaaT033 is an investigational oral pooled fecal microbiotherapy being studied in advanced non-small cell lung cancer (NSCLC). It is being evaluated in patients with resistance to treatment due to antibiotic uptake, given concomitantly with cemiplimab versus best investigator's choice. The drug is in Phase 2 clinical development.

Who makes MaaT033?

MaaT033 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The drug is currently in Phase 2 clinical development for advanced non-small cell lung cancer.

What phase is MaaT033 in?

MaaT033 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. It is being studied in a Phase 2 trial for advanced non-small cell lung cancer in patients with resistance to treatment due to antibiotic uptake.

What clinical trials is MaaT033 in?

MaaT033 is being studied in one active Phase 2 clinical trial, NCT07001618. This randomized, active-controlled trial enrolls 162 patients in France with advanced non-small cell lung cancer. The trial is recruiting participants aged 18 years and older.

Is MaaT033 the same as MaaT033 capsule?

Yes, MaaT033 is also known as MaaT033 capsule. It is an oral pooled fecal microbiotherapy being developed by Regeneron Pharmaceuticals for advanced non-small cell lung cancer. The drug is currently in Phase 2 clinical development.