A Phase III Study of Pre-surgical Chemotherapy and Durvalumab to Treat Operable Stage II/III Non-Small Cell Lung Cancer

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Full Title

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) (WIRB)

Purpose

In this study, researchers are comparing the effectiveness of giving durvalumab immunotherapy with chemotherapy before surgery for stage II or III operable non-small cell lung cancer (NSCLC). Patients will be randomly assigned to receive standard platinum-based chemotherapy with either durvalumab or a placebo before surgery. The treatments are given intravenously (by vein). Patients may continue durvalumab or placebo after surgery at the discretion of their physicians.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage II or III NSCLC that can be completely removed through surgery.
  • Patients may not have previously received immunotherapy or chemotherapy for lung cancer.
  • Patients must not have a known autoimmune condition.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-608-3761.

Protocol

20-397

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators