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 | Biotech Hunter

Enrollment

162

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2032

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

DRUG

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.

DRUG

Cemiplimab

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

DRUG

Cisplatin

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

DRUG

Carboplatine

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

DRUG

Pemetrexed (Alimta)

500mg/m2 at day 1 (d1) q21

DRUG

Bevacizumab

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

DRUG

Paclitaxel

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

DRUG

gemcitabine

1250 or 1000 mg/m2 d1, d8 q21

DRUG

Docetaxel

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

DRUG

Vinorelbine i.v. 25 mg/m²

25-30 mg/m2 d1, d8 q21

DRUG

Vinorelbine oral

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

Trial Locations (1)

94800

Gustave Roussy, Villejuif