Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Summary

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: The study duration will be event-driven, with an estimated duration of approximately 8 years. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Non-small Cell Lung Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

AstraZeneca

Last updated on ClinicalTrials.gov

August 26, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites