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A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT06417814 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2026-05-14

No results posted yet for this study

Summary

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

Dato-DXd

Dato-DXd will be administered as IV infusion.

DRUG

Osimertinib

Osimertinib will be administered orally.

DRUG

Pemetrexed

Pemetrexed will be administered as IV infusion.

DRUG

Carboplatin

Carboplatin will be administered as IV infusion.

DRUG

Cisplatin

Cisplatin will be administered as IV infusion.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2026-09-30
Completion
2028-09-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT06417814 on ClinicalTrials.gov