The first patient has been dosed in the global, randomized TROPION-Lung07 phase III trial evaluating datopotamab deruxtecan + pembrolizumab in patients with previously untreated metastatic NSCLC

TROPION-Lung07 is the third clinical trial collaboration and supply agreement between Daiichi Sankyo and AstraZeneca with a subsidiary of Merck & Co., Inc., Rahway, NJ., USA to evaluate the combination of datopotamab deruxtecan and pembrolizumab. Previous clinical trial collaboration agreements were entered in October 2021 for the TROPION-Lung08 phase III trial and May 2020 for the TROPION-Lung02 phase 1b trial.

TROPION-Lung07 is a global, randomized, open-label, phase III trial assessing the efficacy and safety of datopotamab deruxtecan in combination with pembrolizumab with or without platinum chemotherapy compared with pembrolizumab and platinum chemotherapy in patients with previously untreated, advanced or metastatic non-squamous NSCLC with less than 50% programmed death-ligand (PD-L1) expression (tumor proportion score [TPS] < 50%) and without actionable genomic alterations. Eligible participants in the three-arm study will be randomized in a 1:1:1 ratio to the following intervention arms: Arm A (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV plus platinum chemotherapy every three weeks), Arm B (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV every three weeks), and Arm C (pembrolizumab 200 mg IV plus pemetrexed [500 mg/m2] plus platinum chemotherapy every three weeks).

The primary endpoints of TROPION-Lung07 are progression-free survival (PFS) as assessed by blinded independent central review and overall survival. Secondary endpoints include objective response rate, duration of response, time to response, disease control rate as assessed by both investigator and blinded independent central review, PFS as assessed by investigator, PFS2 and safety. TROPION-Lung07 will enroll approximately 975 patients at sites in North America, South America, Europe, Asia and Oceania.