TROPION-Lung17 TROP2 biomarker directed Phase 3 trial of DATROWAY initiated in patients with previously treated advanced nonsquamous non-small cell lung cancer

CAR-T Digest - August 2020

Weekly Digest - January 2026

13 January 2026: TROPION-Lung17 TROP2 biomarker directed Phase 3 trial of DATROWAY initiated in patients with previously treated advanced non-squamous non-small cell lung cancer

The first patient has been dosed in the Phase 3 TROPION-Lung17 trial, marking the initiation of a biomarker-directed study evaluating DATROWAY versus docetaxel in patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have progressed after immunotherapy and platinum-based chemotherapy
This trial is the first Phase 3 study to prospectively enroll patients based on TROP2 NMR positivity, a novel computational pathology biomarker designed to identify those most likely to benefit from TROP2-directed therapy in a setting where traditional chemotherapy remains the standard of care beyond first line
TROPION-Lung17 builds on retrospective findings from earlier studies, including TROPION-Lung01, which demonstrated a correlation between TROP2 NMR positivity and improved clinical outcomes, providing the rationale for a precision-medicine approach in this hard-to-treat population
By incorporating quantitative continuous scoring through AstraZeneca’s computational pathology platform, the trial aims to determine whether biomarker-selected patients can achieve improved survival compared with standard chemotherapy in the second line and later settings
TROPION-Lung17 is the ninth Phase 3 trial of DATROWAY in non-small cell lung cancer, further expanding a broad late-stage development program that includes multiple ongoing studies in both first line and previously treated advanced NSCLC populations