Randomized Phase 3 Trial of Durvalumab as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 Non-Small Cell Lung Cancer

EA5181 is a randomized open-label phase 3 trial for patients with unresectable stage 3 non-small cell lung cancer (NSCLC). The study aims to determine if concurrent durvalumab with standard platinum doublet chemotherapy and radiation, followed by consolidative durvalumab, is a more effective treatment approach than the same concurrent chemoradiotherapy regimen alone followed by consolidative durvalumab. The primary objective is to evaluate whether there is an improvement in overall survival in the group that receives concurrent and consolidative therapy with durvalumab.

In 2018, the PACIFIC trial demonstrated that one year of consolidation durvalumab after concurrent chemo/radiation was found to increase both overall survival and progression-free survival, establishing consolidation durvalumab as the new standard of care. However, additional studies suggest immune checkpoint inhibitors such as durvalumab may be even more effective when combined with cytotoxic therapy such as chemotherapy and/or radiation.

Patients assigned to the concurrent and consolidative therapy group will receive platinum doublet chemotherapy and concurrent thoracic radiotherapy, as well as durvalumab. Patients assigned to the consolidative therapy alone group will receive platinum doublet chemotherapy and concurrent thoracic radiotherapy only. Patients from both groups will then proceed to Step 2, consolidative durvalumab every four weeks for up to one year.

This study is led by Nathan Pennell, MD, PhD (Cleveland Clinic), pictured here on the left, and John Varlotto, MD (University of Massachusetts), pictured on the right.

Learn more about this trial at ecog-acrin.org.