Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

Active:	Yes
Cancer Type:	Lung Cancer Unknown Primary	NCT ID:	NCT05555732
Trial Phases:	Phase III	Protocol IDs:	DS1062-A-U303 (primary) NCI-2023-06122 2022-500802-16-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Daiichi Sankyo
NCI Full Details:	http://clinicaltrials.gov/show/NCT05555732

Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan
(Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with
pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced
or metastatic non-squamous non-small cell lung cancer (NSCLC).

Objectives

The primary objectives of the study are Progression Free Survival (PFS) and Overall
Survival (OS) as first line therapy in participants with programmed death-ligand 1
(PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic
alternations.

Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus
pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus
pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at
investigator discretion. The study will be divided into three periods: Screening Period
(including tissue screening), Treatment Period, and Follow-up Period.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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