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 lung cancer (NSCLC)

Trial Details

NCT ID
NCT04105270
Phase
PHASE2
Sponsor
Masonic Cancer Center, University of Minnesota
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Oral Restorative Microbiota Therapy (RMT) Capsules
  • Durvalumab 1500 mg IV
  • Cisplatin/pemetrexed or Carboplatin/pemetrexed
  • Placebo
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Brainerd, Minnesota, United States|46.35802,-94.20083
  • Deer River, Minnesota, United States|47.333,-93.79272
  • Detroit Lakes, Minnesota, United States|46.81718,-95.84533
  • Duluth, Minnesota, United States|46.78327,-92.10658

Key Eligibility Criteria

  • Histologically or cytologically confirmed adenocarcinoma of the lung that is unresectable stage IIIB/C or stage IV, does not have an EGFR sensitizi…
  • Measurable disease based on RECIST 1.1
  • Tumor sample requirements
  • Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for biomarker and genomic analysis. A minimum o…

For full eligibility, visit ClinicalTrials.gov.

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