A Phase III Study of Presurgical Osimertinib Alone or with Chemotherapy versus Chemotherapy Alone for Patients with EGFR Mutation-Positive Operable Non-Small Cell Lung Cancer

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Full Title

A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA) (WIRB)

Purpose

Osimertinib is a standard treatment for non-operable, advanced non-small cell lung cancer (NSCLC) that has a change (mutation) in the EGFR gene. In this study, researchers want to see if adding osimertinib to standard chemotherapy before lung cancer surgery is more effective than standard chemotherapy or osimertinib alone in patients with operable EGFR-mutated NSCLC. Patients will be randomly assigned to one of these groups:

  • Chemotherapy plus placebo
  • Chemotherapy plus osimertinib
  • Osimertinib alone

The chemotherapy is given intravenously (by vein) and osimertinib is taken orally (by mouth).

Eligibility

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

  • Patients must have operable (stage II-IIIB N2) non-squamous NSCLC that has an EGFR mutation and has not yet been treated with anticancer medication.
  • The tumor’s EGFR mutation status must be confirmed by the study sponsor.
  • Patients must be determined by a surgeon to be physically strong enough for the required lung surgery.
  • This study is for patients age 18 and older.

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

Protocol

21-244

Phase

III

Investigator

Co-Investigators