TROPION-Lung15
Research type
Research Study
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)
IRAS ID
1010246
Contact name
Ian Martin
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat non-small cell lung cancer (NSCLC) after it has been treated with a drug called osimertinib. In this trial, the researchers want to learn more about a drug called datopotamab deruxtecan (Dato-DXd) which is designed to kill cancer cells that have a protein called TROP2, which is found at high levels on the surface of some cancer cells. The researchers think that Dato-DXd, alone or combined with osimertinib, could work better than chemotherapy to treat NSCLC that got worse during previous osimertinib treatment and that has certain EGFR mutations. The study will compare these treatments to the current standard of care of platinum-based doublet chemotherapy. The study will be open-label, sponsor-blind, and randomised, meaning participants will be assigned to treatment groups by chance. There will be three treatment arms. The primary objective is to compare the effectiveness of Dato-DXd with and without Osimertinib to chemotherapy. The study will also assess the safety and tolerability of Dato-DXd with or without osimertinib compared to chemotherapy. The study will be conducted at approximately 225 sites globally across an estimated 23 countries. This study is being sponsored by AstraZeneca AB.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0220
Date of REC Opinion
15 Jan 2025
REC opinion
Further Information Favourable Opinion