NCT04105270

RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) in Combination With Durvalumab (MEDI4736) and Chemotherapy in Untreated Patients With Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, active-controlled, parallel-group, double-blind Phase II trial, of oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab (MEDI4736) plus chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)

Conditions

• Adenocarcinoma of Lung
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Oral Restorative Microbiota Therapy (RMT) Capsules	Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
DRUG	Durvalumab 1500 mg IV	Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab
DRUG	Cisplatin/pemetrexed or Carboplatin/pemetrexed	Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W
OTHER	Placebo	Sixteen doses of oral placebo capsules given weekly

Timeline

• Start date: 2022-11-30
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2019-09-26
• Last updated: 2025-09-11

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study