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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer
Status: Recruiting
CCS - test OnCore size limitation
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:
• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Conditions:
Cancer, Respiratory System
Keywords:
Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
Contact(s): Amanda Garcia - garc0276@umn.edu
Phase: PHASE2
IRB Number: STUDY00020829
System ID: 27034
See this study on ClinicalTrials.gov