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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: Recruiting Phase 2 study of Lung Cancer and Adenocarcinoma of Lung, sponsored by Masonic Cancer Center, University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy
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 |
What NCT04105270 shows while recruiting
NCT04105270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (91% lower).
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 lists 10 locations in 2 states (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.
Learn More About Clinical Trials
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Where NCT04105270's enrollment target sits among peer trials
82 212th of 409 higher than 198 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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