The clinical trial for Phase III Tropian Lung17’s— first patient received the dose, marking a key milestone in the evaluation of Datroway (datopotamab deruxtecan) for patients with Trop2 NMR-positive locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC). The study compares Datroway with standard chemotherapy docetaxel in patients whose disease has progressed following immunotherapy and platinum-based chemotherapy and who have no actionable genomic alterations.

Datroway is a Trop2-directed Antibody-Drug Conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. The trial is the first Phase III study to prospectively enroll patients based on its Normalised Membrane Ratio (NMR), a biomarker identified using AstraZeneca’s Quantitative Continuous Scoring (QCS) computational pathology platform.

Tropian-Lung17 builds on encouraging findings from earlier clinical studies, including Tropian-Lung01, which demonstrated a correlation between Trop2 NMR positivity and improved outcomes in patients treated with Datroway. The trial aims to determine whether a biomarker-driven approach can improve survival outcomes compared with current standard-of-care chemotherapy in the second-line and later treatment settings.

The global, randomised, open-label Phase III trial will enroll approximately 400 patients across Asia, Europe, and North America. Participants with centrally confirmed TROP2 NMR-positive tumors will be randomised 1:1 to receive either Datroway or docetaxel. The dual primary endpoints are progression-free survival and overall survival, with key secondary endpoints including overall response rate, duration of response and safety.

Tropian-Lung17 is the ninth Phase III trial of Datroway in NSCLC and part of a broader global development program exploring the ADC across multiple cancer types. Daiichi Sankyo and AstraZeneca are also collaborating with Roche Tissue Diagnostics to co-develop the Ventana Trop2 RxDx Device, an AI-powered companion diagnostic that has received Breakthrough Device Designation from the US FDA.

Through TROPION-Lung17, the companies aim to advance a precision medicine approach in advanced lung cancer, where traditional chemotherapy remains the standard of care after disease progression on immunotherapy.