Citations 1
Pembrolizumab with or without chemotherapy among older adults with advanced lung adenocarcinoma: a national, nonrandomized open-label phase 2 trial (Alliance A171901)
Lee, Minji K. , Kour, Oudom, Satele, Daniel , Presley, Carolyn J. , Le-Rademacher, Jennifer, Ojelabi, Michael, Chow, Selina, Stinchcombe, Thomas E, Homan, Sherri , Finnes, Heidi D. , Waqar, Saiama, Jatoi, Aminah , Le‐Rademacher, Jennifer , Chow, Selina , Ojelabi, Michael Olayiwola , Le-Rademacher, Jennifer G , Ojelabi, Michael O , Presley, Carolyn J , Chow, Selina , Wong, Melisa L. , Stinchcombe, Thomas E. , Waqar, Saiama N
JNCI: Journal of the National Cancer Institute | May 15, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
Abstract Background Older adults remain underrepresented in prospective trials of immunotherapy for advanced lung cancer. To estimate pembrolizumab adverse events, we conducted a multicenter, nonrandomized, open-label phase 2 trial of oncologist-choice first-line pembrolizumab with or without chemotherapy for older adults with advanced lung adenocarcinoma. Methods Alliance for Clinical Trials in Oncology A171901 enrolled patients aged 70 years and older with stage IV or recurrent lung adenocarcinoma starting oncologist’s choice of first-line pembrolizumab with or without carboplatin and pemetrexed. The primary endpoint was the proportion of patients experiencing a solicited grade 3 or greater adverse event within 6 months. Secondary endpoints included overall survival, quality of life, and association of a geriatric assessment toxicity risk score with severe adverse events. Results Among 95 evaluable patients, 43 (45.3%) received pembrolizumab and 52 (54.7%) received pembrolizumab plus chemotherapy. Median age was 77 years (range = 70-92 years); 11.6% had an E Performance Status of 2 or higher. During 6 months of treatment, 25.6% (95% CI = 13.5% to 41.2%) experienced a solicited grade 3 or greater adverse event in the monotherapy group and 42.3% (95% CI = 28.7% to 56.8%) in the combination group. Median overall survival was 16.4 months (95% CI = 10.1 to not estimable) with monotherapy and 29.9 months (95% CI = 16.4 to not estimable) with combination therapy. Quality of life worsened during treatment. The geriatric assessment toxicity risk score was not associated with severe adverse events with pembrolizumab with or without chemotherapy. Conclusions Older adults with advanced lung adenocarcinoma receiving pembrolizumab with or without chemotherapy had comparable adverse event rates to those in prior registration trials that excluded medically frail patients. These findings can inform shared decision making and support inclusion of older adults in future trials. Clinical Trial NCT04533451 (https://clinicaltrials.gov/study/NCT04533451)