Chemo-Immunotherapy Versus Immunotherapy Alone for Older Adults With Advanced Non-Small Cell Lung Cancer The ACHIEVE Study

What this Trial Is About

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer NSCLC stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49 and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, andor PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial