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 Sep 2, 2026, 4:01 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

Study identification

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

Conditions and interventions

Conditions

Non-small Cell Lung Cancer

Interventions

Osimertinib Drug
Datopotamab Deruxtecan 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: Aug 25, 2026

2024 – 2031

United States locations

U.S. sites: 37
U.S. states: 17
U.S. cities: 35

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	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	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	Tacoma	Washington	98405	Recruiting
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 Aug 25, 2026 · Synced Sep 2, 2026

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

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