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A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153

Status: Recruiting
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• at least 18 years old
• diagnosis of non-small cell lung cancer (NSCLC)
• tumor size between 1 and 4 cm in size
• had a complete surgical resection of stage I NSCLC between 4-12 weeks ago
• able to walk and carry out basic activities of living
• women are willing to use highly effective birth control for 120 days after last dose of study drug
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer
• active additional cancer that is progressing or has required treatment within the past 2 years
• diagnosis of immunodeficiency or receiving chronic steroid therapy
• women who are pregnant or breast feeding
• other active diseases (study staff will review)
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Lung Cancer, Lung Cancer, Non-small Cell Lung Cancer (NSCLC)
Study Contact: Naomi Fujioka - fujio002@umn.edu
Principal Investigator: Naomi Fujioka
Phase: PHASE2
IRB Number: STUDY00010745
See this study on ClinicalTrials.gov