drugset / Trial / NCT06899126

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

NCT06899126

Phase 3 Recruiting 686 enrolled Daiichi Sankyo Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Timeline

Start
2025-10-24
Primary completion
2030-04-24
Completion
2032-11-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous