Randomized Phase III Trial of MEDI4736 (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 III trial for patients with unresectable stage 3 non-small cell lung cancer (NSCLC). The study aims to determine if concurrent MEDI4736 (durvalumab) with standard platinum doublet chemotherapy and radiation, followed by consolidative MEDI4736 (durvalumab), is a more effective treatment approach than the same concurrent chemoradiotherapy regimen alone followed by consolidative MEDI4736 (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 MEDI4736 (durvalumab).

In 2018, the PACIFIC trial demonstrated that one year of consolidation MEDI4736 (durvalumab) after concurrent chemo/radiation was found to increase both overall survival and progression-free survival, establishing consolidation MEDI4736 (durvalumab) as the new standard of care. However, additional studies suggest immune checkpoint inhibitors such as MEDI4736 (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 MEDI4736 (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 MEDI4736 (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.