A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Daiichi Sankyo
Summary
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.
Description
The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC. Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study. * Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures. * Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent. * Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subj…
Interventions
- DrugDatopotamab Deruxtecan
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
- DrugPembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Locations (243)
- Ironwood Cancer and Research CenterChandler, Arizona
- UCLA HemOnc - Clinical Research UnitLos Angeles, California
- Compassionate Cancer Care Medical GroupRiverside, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Ridley-Tree Cancer CenterSanta Barbara, California
- PIH Health Whittier HospitalWhittier, California