Standard chemotherapy has shown promising outcomes in the treatment of small-cell lung cancer, but its efficacy in non-small cell lung cancer remains uncertain. Durvalumab is an immunotherapy that may be used to treat small-cell lung cancer, but whether it would be more effective with or without tremelimumab (a human monoclonal antibody) is not clear. This study aims to compare the efficacy of durvalumab with and without tremelimumab with standard chemotherapy in patients with metastatic non–small cell lung cancer.
In this open-label, phase 3 randomized clinical trial, a total of 1,118 patients with treatment-naive, metastatic non–small cell lung cancer were included. The patients were randomly assigned in a 1:1:1 ratio to receive durvalumab alone, durvalumab plus tremelimumab, or platinum-based doublet chemotherapy. The primary outcomes of the study were overall survival and adverse outcomes.
Out of 1,118 randomized patients, 488 had ≥25% of tumor cells expressing PD-L1. Among those patients, median overall survival was 16.3 months with durvalumab alone, 11.9 months with durvalumab plus tremelimumab, and 12.9 months with chemotherapy. The rate of adverse events of grade 3 or higher was 14.9%, 22.9%, and 33.8% in the three groups, respectively.
The research concluded that durvalumab alone was superior to durvalumab plus tremelimumab and chemotherapy in terms of median overall survival and safety.