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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06350097

Public ClinicalTrials.gov record NCT06350097. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 8, 2026, 5:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study identification

NCT ID
NCT06350097
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
582 participants

Conditions and interventions

Interventions

  • Datopotamab Deruxtecan Drug
  • Osimertinib Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 28, 2024
Primary completion
Mar 20, 2028
Completion
Aug 28, 2031
Last update posted
May 5, 2026

2024 – 2031

United States locations

U.S. sites
36
U.S. states
17
U.S. cities
34
Facility City State ZIP Site status
Research Site Fountain Valley California 92708 Suspended
Research Site Los Alamitos California 90720 Recruiting
Research Site Los Angeles California 90017 Recruiting
Research Site Los Angeles California 90033 Recruiting
Research Site Orange California 92868 Not yet recruiting
Research Site San Diego California 92123 Recruiting
Research Site Santa Monica California 90404 Recruiting
Research Site Walnut Creek California 94598 Recruiting
Research Site New Haven Connecticut 06510 Recruiting
Research Site Washington D.C. District of Columbia 20037 Withdrawn
Research Site Jacksonville Florida 32256 Recruiting
Research Site Ocala Florida 34474 Recruiting
Research Site Orange City Florida 32763 Recruiting
Research Site Honolulu Hawaii 96819 Withdrawn
Research Site Chicago Illinois 60611 Withdrawn
Research Site Hinsdale Illinois 60521 Recruiting
Research Site North Chicago Illinois 60064 Recruiting
Research Site Fort Wayne Indiana 46845 Recruiting
Research Site Bethesda Maryland 20817 Recruiting
Research Site Detroit Michigan 48201 Recruiting
Research Site Saint Paul Minnesota 55102 Recruiting
Research Site Bridgeton Missouri 63044 Withdrawn
Research Site St Louis Missouri 63110 Recruiting
Research Site Las Vegas Nevada 89169 Recruiting
Research Site Brooklyn New York 11212 Not yet recruiting
Research Site New York New York 10065 Recruiting
Research Site Dallas Texas 75390 Withdrawn
Research Site Houston Texas 77030 Recruiting
Research Site Houston Texas 77090 Withdrawn
Research Site Webster Texas 77598 Recruiting
Research Site Woodway Texas 76712 Recruiting
Research Site Fairfax Virginia 22031 Recruiting
Research Site Fort Belvoir Virginia 22060 Recruiting
Research Site Midlothian Virginia 23114 Recruiting
Research Site Seattle Washington 98104 Withdrawn
Research Site Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 130 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06350097, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06350097 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →