82
Participants
Start Date
November 30, 2022
Primary Completion Date
January 31, 2028
Study Completion Date
January 31, 2028
Oral Restorative Microbiota Therapy (RMT) Capsules
Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
Durvalumab 1500 mg IV
Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab
Cisplatin/pemetrexed or Carboplatin/pemetrexed
Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W
Placebo
Sixteen doses of oral placebo capsules given weekly
RECRUITING
Masonic Cancer Center, University of Minnesota, Minneapolis
RECRUITING
MNCCTN Essentia Health Hibbing Clinic, Hibbing
RECRUITING
MNCCTN Essentia Health Virginia Clinic, Virginia
RECRUITING
MNCCTN Essentia Health Duluth, Duluth
RECRUITING
MNCCTN Essentia Health St. Joseph's Brainerd Medical Center, Brainerd
RECRUITING
MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic, Detroit Lakes
RECRUITING
MNCCTN Essentia Health Fosston, Fosston
RECRUITING
MNCCTN Essentia Health Deer River, Deer River
NOT_YET_RECRUITING
Dr. Amit Kulkarni, Phoenix
RECRUITING
MNCCTN Essentia Health Sandstone, Sandstone
Masonic Cancer Center, University of Minnesota
OTHER