TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC
Journal
Future oncology (London, England)
Journal Volume
19
Journal Issue
21
Date Issued
2023-07
Author(s)
Levy, Benjamin P
Felip, Enriqueta
Reck, Martin
Cappuzzo, Federico
Yoneshima, Yasuto
Zhou, Caicun
Rawat, Siddhartha
Xie, Jingdong
Basak, Priyanka
Xu, Lu
Sands, Jacob
Abstract
Pembrolizumab monotherapy is a standard first-line treatment for PD-L1-high advanced non-small-cell lung cancer (NSCLC) without actionable genomic alterations (AGA). However, few patients experience long-term disease control, highlighting the need for more effective therapies. Datopotamab deruxtecan (Dato-DXd), a novel trophoblast cell-surface antigen 2-directed antibody-drug conjugate, showed encouraging safety and antitumor activity with pembrolizumab in advanced NSCLC. We describe the rationale and design of TROPION-Lung08, a phase III study evaluating safety and efficacy of first-line Dato-DXd plus pembrolizumab versus pembrolizumab monotherapy in patients with advanced/metastatic NSCLC without AGAs and with PD-L1 tumor proportion score ≥50%. Primary end points are progression-free survival and overall survival; secondary end points include objective response rate, duration of response, safety and presence of antidrug antibodies. Clinical trial registration: NCT05215340 (ClinicalTrials.gov).
Subjects
Dato-DXd; PD-1; PD-L1; TROP2; antibody–drug conjugate; datopotamab deruxtecan; immuno-oncology; non-small-cell lung cancer; pembrolizumab
SDGs
Type
review