A Phase 3 Study of Dato-DXd With or Without Osimertinib Versus Chemotherapy for People With Non-Small Cell Lung Cancer

Full Title

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

Purpose

Researchers are assessing Dato-DXd alone or with osimertinib and comparing it with standard chemotherapy for advanced lung cancer. The people in this study have non-small cell lung cancer (NSCLC) that has a mutation (change) in the EGFR gene. In addition, their cancer keeps growing on osimertinib treatment.

If you join this study, you will be randomly assigned to get one of these treatments:

• Dato-DXd plus osimertinib. Dato-DXd is give intravenously (by vein) and osimertinib is taken orally (by mouth).
• Dato-DXd alone.
• Chemotherapy with pemetrexed plus either cisplatin or carboplatin. These drugs are given intravenously.

Who Can Join

To join this study, there are a few conditions. You must:

• Have locally advanced or metastatic NSCLC with an EGFR mutation that keeps growing after osimertinib.
• Have recovered from the serious side effects of prior therapies before getting the study treatment.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Helena Yu’s office at 646-608-3912.