Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07001618 | 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 | PHASE2 | RECRUITING | 162 | — | — | Nov 17, 2025 | Sep 1, 2032 | Apr 3, 2026 | 6 | France |
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.
| Arm | Type | Description |
|---|---|---|
| Combination of MaaT033 + Cemiplimab (CB) | EXPERIMENTAL | 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. |
| Best Investigator's Choice (BIC) | ACTIVE_COMPARATOR | Patients will receive chemotherapy according to current standard of care protocols according to investigator's best choice from current guidelines combinations. |
| Name | Type | Description |
|---|---|---|
| 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) |
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...