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Clinical trial of Dato-DXd, with or without osimertinib, versus platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer with EGFR mutation
THE OBJECTIVE OF THIS STUDY IS TO EVALUATE WHETHER THE DRUG DATO-DXD ALONE (MONOTHERAPY), OR IN COMBINATION WITH OSIMERTINIB, CAN SAFELY ENABLE LONGER DISEASE CONTROL COMPARED TO THE CURRENT STANDARD OF CARE (SOC) CHEMOTHERAPY TREATMENT OPTION IN PATIENTS WHO HAVE FAILED PRIOR TREATMENT WITH OSIMERTINIB.
Technical Summary
- PHASE III, RANDOMIZED, OPEN-LABEL, SPONSOR-BLINDED STUDY OF DATO-DXD, WITH OR WITHOUT OSIMERTINIB, VERSUS PLATINUM-BASED BICHEMOTHERAPY IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EGFR MUTATION WHOSE DISEASE HAS PROGRESSED WITH PRIOR TREATMENT WITH OSIMERTINIB (TROPION-LUNG15)
- Code EudraCT: 2024-511362-37
- Protocol number: D516KC00001
- Promoter: Astra Zeneca AB
- Molecule/Drug: Dato-DXd solo en combinación con osimertinib
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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