NCI-2025-02942

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)

This Phase III research study, called TROPION‑Lung15, is comparing three different treatment approaches in adults with EGFR-mutated advanced non–small cell lung cancer (NSCLC) who previously progressed on osimertinib (a standard targeted therapy). One group gets an experimental drug called Dato‑DXd by IV (an antibody-drug conjugate targeting TROP2); the second group receives Dato‑DXd plus continued osimertinib, and the third group receives the usual platinum-based chemotherapy (pemetrexed with cisplatin/carboplatin). The main goal is to see which approach keeps the cancer from worsening the longest (progression-free survival), while also tracking side effects and overall survival. By comparing these options, researchers hope to find a better next-step treatment for patients whose cancer stops responding to osimertinib.

Advanced: Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

EGFR: Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Non-small cell lung cancer: A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT06417814

Clinical Trial Site: Einstein

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