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
Masonic Cancer Center, University of Minnesota
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the lung that is unresectable stage IIIB/C or stage IV, does not have an EGFR sensitizing (activating) mutation or ALK or ROS1 translocation. BRAF, RET, NTRK, MET ex 14 splice site mutation * 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 of 10 unstained slides should be available for evaluation. * Known PD-L1 TC expression status assayed by…