Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
NCT04105270 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- OTHER Placebo
- DRUG Oral Restorative Microbiota Therapy (RMT) Capsules
- DRUG Durvalumab 1500 mg IV
- DRUG Cisplatin/pemetrexed or Carboplatin/pemetrexed
Study Locations (10)
Minnesota
- MNCCTN Essentia Health St. Joseph's Brainerd Medical Center — Brainerd
- MNCCTN Essentia Health Deer River — Deer River
- MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic — Detroit Lakes
- MNCCTN Essentia Health Duluth — Duluth
- MNCCTN Essentia Health Fosston — Fosston
- MNCCTN Essentia Health Hibbing Clinic — Hibbing
- Masonic Cancer Center, University of Minnesota — Minneapolis
- MNCCTN Essentia Health Sandstone — Sandstone
- MNCCTN Essentia Health Virginia Clinic — Virginia
Arizona
- Dr. Amit Kulkarni — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04105270
The ClinicalTrials.gov registry entry for NCT04105270 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 154 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04105270 reports 10 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04105270 about?
NCT04105270 is a clinical study titled "RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial". 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 l...
What is the current status of trial NCT04105270?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2022-11-30. Estimated completion is 2028-01.
What conditions does trial NCT04105270 study?
This clinical trial studies the following conditions: Lung Cancer, Adenocarcinoma of Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04105270?
The interventions under investigation include: Placebo (OTHER), Oral Restorative Microbiota Therapy (RMT) Capsules (DRUG), Durvalumab 1500 mg IV (DRUG), Cisplatin/pemetrexed or Carboplatin/pemetrexed (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04105270?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 154 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04105270 being conducted?
This trial has 10 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.