Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To estimate the adverse event profile of MK-3475 (pembrolizumab) over the first six months of treatment, in non-small cell lung cancer patients who are 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: This is an observational study. 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 or 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients complete questionnaires as well as undergo computed tomography (CT) scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study. GROUP B: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Patients also receive pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles with pemetrexed and carboplatin repeat every 21 days in the absence. Additionally, patients complete questionnaires as well as undergo CT scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study. After completion of study treatment, patients are followed up annually for up to 5 years after registration.
Age
70–any
Sex
ALL
Healthy volunteers
Not accepted
