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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

Transitioning from individual clerkship, summative, graded evaluations to integrated, cross-clerkship, trajectory-driven assessments presents a challenge for clerkships and medical schools. We describe innovations and observations from a transition period during which the internal medicine clerkship integrated EPAs as a new, additional form of evaluation. We identify strategies that are effective in educating the hundreds of residents and evaluators utilizing these new evaluations, ranging from real-time faculty development tools to methods of student empowerment. We review which EPAs are most readily integrated into the workflow of the medicine clerkship and identify those that require a more intensive, targeted approach. We also reflect on the ongoing challenges to implementation, including specific faculty development needs and identifying threshold criteria across all courses that identify students ready for residency.

I'm interested

Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting 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)
Interventions:

Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed, Drug: Durvalumab 1500 mg IV, Drug: Oral Restorative Microbiota Therapy (RMT) Capsules, Other: Placebo

Conditions:

Cancer, Respiratory System

Keywords:

Adenocarcinoma of Lung, Clinics and Surgery Center (CSC), Lung Cancer

Contact(s): Amanda Garcia - garc0276@umn.edu
Phase: PHASE2
IRB Number: STUDY00020829
System ID: 27034
See this study on ClinicalTrials.gov

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