NCT04105270

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

Recruiting now Phase 2 Last updated 10 September 2025

What this trial tests

Phase 2 trial testing Oral Restorative Microbiota Therapy (RMT) Capsules in Adenocarcinoma of Lung in 82 participants. Currently enrolling.

Timeline

30 November 2022

Primary endpoint
1 January 2028

1 January 2028

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	82
Start date	30 November 2022
Primary completion	1 January 2028
Estimated completion	1 January 2028
Sites	10 locations across United States

Drugs / interventions tested

• Oral Restorative Microbiota Therapy (RMT) Capsules — full drug profile →
• Durvalumab 1500 mg IV — full drug profile →
• Cisplatin/pemetrexed or Carboplatin/pemetrexed — full drug profile →
• Placebo

Conditions studied

• Adenocarcinoma of Lung — all drugs for Adenocarcinoma of Lung →
• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

18 and older, any sex, with Adenocarcinoma of Lung or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of patients experiencing Progression Free Survival (PFS)
  Time frame: 3 Years
  Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy
• Safety and tolerability of RMT
  Time frame: 2 Years
  Safety and tolerability of RMT in combination with durvalumab or durvalumab + chemotherapy as assessed by the incidence of adverse events

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota-mediated immunomodulation in tumor.
   Liu X, Chen Y, Zhang S, Dong L. · · 2021 · cited 76× · PMID 34217349 · DOI 10.1186/s13046-021-01983-x
2. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255
3. Gut-lung axis: role of the gut microbiota in non-small cell lung cancer immunotherapy.
   Zhang H, Xu Z. · · 2023 · cited 20× · PMID 38074650 · DOI 10.3389/fonc.2023.1257515
4. The Gut Microbiome from a Biomarker to a Novel Therapeutic Strategy for Immunotherapy Response in Patients with Lung Cancer.
   Duttagupta S, Hakozaki T, Routy B, Messaoudene M. · · 2023 · cited 20× · PMID 37999101 · DOI 10.3390/curroncol30110681
5. Commensal Microbiota and Cancer Immunotherapy: Harnessing Commensal Bacteria for Cancer Therapy.
   Bae J, Park K, Kim YM. · · 2022 · cited 14× · PMID 35291651 · DOI 10.4110/in.2022.22.e3
6. Deciphering the intratumor microbiota in malignant gastrointestinal tumors: multifaceted interplay and clinical implications.
   Tang B, Lin Y, Jiang T, Chen Y, et al · · 2026 · cited 1× · PMID 41593640 · DOI 10.1186/s12964-025-02303-y
7. Onco-biome in pharmacotherapy for lung cancer: a narrative review.
   Tateishi AT, Okuma Y. · · 2022 · cited 1× · PMID 36519027 · DOI 10.21037/tlcr-22-299
8. Immunotherapy with guts: a review of microbial therapeutic adjuncts for immunotherapy in solid tumors.
   Pum K, Lou E, Goffredo P, Jahansouz C, et al · · 2026 · PMID 41967083 · DOI 10.1093/oncolo/oyag131