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

Protocol No

DAIICHI-DS1062-A-U304

Staff Member

Jonathan Thompson

Phase

III

Summary

The main purpose of this research study is to gather information about Datopotamab Deruxtecan (Dato-DXd) in combination with Pembrolizumab versus Pembrolizumab alone in treating your disease. Dato-DXd is an investigational drug, meaning it is being studied in clinical trials like this one and has not been approved by the FDA for sale or use in your disease. Pembrolizumab is approved by the US Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer.

Objective

This project is being done to gather information about Datopotamab Deruxtecan (Dato-DXd) in combination with Pembrolizumab versus Pembrolizumab alone in treating metastatic NSCLC.

Study Sites

Froedtert Hospital

Status

OPEN TO ACCRUAL

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)