Clinical Trial Details

Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer

Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)

Current Status: Open

Phase: II

Principal Investigator: Sharma, Bhavina

Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu

Eligibility: https://clinicaltrials.gov/ct2/show/NCT04533451?term=NCT04533451&draw=2&rank=1#eligibility

Summary
PRIMARY OBJECTIVE: I. To estimate the adverse event profile of MK-3475 (pembrolizumab) in non-small cell lung cancer patients who are age 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting. SECONDARY OBJECTIVES: I. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire. III. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up annually for up to 5 years after registration.