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Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

NCT06357533 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2026-05-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Conditions

Interventions

DRUG

Datopotamab Deruxtecan

Datopotamab Deruxtecan IV (intravenous)

DRUG

Rilvegostomig

Rilvegostomig IV (intravenous)

DRUG

Pembrolizumab

Pembrolizumab IV (intravenous)

Sponsors & Collaborators

Principal Investigators

  • Suresh S. Ramalingam, MD · Emory University, Atlanta, Georgia, United States of America.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2029-12-28
Completion
2029-12-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

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 NCT06357533 on ClinicalTrials.gov