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NCT04105270 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lung Cancer and Adenocarcinoma of Lung, sponsored by Masonic Cancer Center, University of Minnesota.

Recruiting
Registry status
Phase 2
Development phase
82
Enrollment target
10
Study locations

NCT04105270 is a Phase 2 study of Lung Cancer and Adenocarcinoma of Lung that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 82 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 2 states.

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The verdict

NCT04105270, a Phase 2 study of Lung Cancer and Adenocarcinoma of Lung, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.

RECRUITING
Registry status
Phase 2
Development phase
82 participants
Enrollment target
10
Study locations

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

Lung Cancer Adenocarcinoma of Lung

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

FieldValue
Enrollment Target 82 participants
Start Date 2022-11-30
Est. Completion 2028-01
Phase Phase 2

Sponsor

Masonic Cancer Center, University of Minnesota

249 total trials

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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, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.

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.

NCT04105270 reports 10 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Arizona.

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.

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).

Who is sponsoring clinical trial NCT04105270?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.