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Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

NCT05215340 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Datopotamab Deruxtecan

Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2028-02-29
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215340 on ClinicalTrials.gov