Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

ClinicalTrials.gov ID: NCT05215340

Public ClinicalTrials.gov record NCT05215340. 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 6, 2026, 8:26 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 Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

Study identification

NCT ID: NCT05215340
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Daiichi Sankyo; Industry
Enrollment: 740 participants

Conditions and interventions

Conditions

Metastatic Non Small Cell Lung Cancer

Interventions

Datopotamab Deruxtecan Drug
Pembrolizumab 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: Mar 3, 2022
Primary completion: Feb 28, 2028
Completion: Apr 29, 2028
Last update posted: Jan 6, 2026

2022 – 2028

United States locations

U.S. sites: 36
U.S. states: 12
U.S. cities: 25

Facility	City	State	ZIP	Site status
Ironwood Cancer and Research Center	Chandler	Arizona	85224	Recruiting
UCLA HemOnc - Clinical Research Unit	Los Angeles	California	90095	Recruiting
Compassionate Cancer Care Medical Group	Riverside	California	92501	Withdrawn
UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	94158	Withdrawn
Ridley-Tree Cancer Center	Santa Barbara	California	93105	Recruiting
PIH Health Whittier Hospital	Whittier	California	90602	Recruiting
The Oncology Institute of Hope and Innovation	Whittier	California	90603	Terminated
Uch-Mhs D/B/A Memorial Health System	Colorado Springs	Colorado	80909	Recruiting
Johns Hopkins University	Baltimore	Maryland	21205	Recruiting
American Oncology Partners of Maryland	Bethesda	Maryland	20817	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02115	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Recruiting
DFCI - Steward St. Elizabeth's Medical Center	Boston	Massachusetts	02215	Withdrawn
Dana Farber Cancer Institute - Foxborough	Foxborough	Massachusetts	02035	Terminated
Dana Farber Cancer Institute - Milford Medical Center	Milford	Massachusetts	01757	Withdrawn
DFCI - South Shore Hospital	South Weymouth	Massachusetts	02190	Terminated
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	03766	Recruiting
Astera Cancer Care	East Brunswick	New Jersey	08816	Recruiting
Regional Cancer Care Associates LLC	Freehold	New Jersey	07728	Recruiting
Cooperman Barnabas Medical Center	New Brunswick	New Jersey	08901	Terminated
The Valley Hospital	Paramus	New Jersey	07652	Recruiting
Montefiore Medical Center	The Bronx	New York	10461	Recruiting
Arizona Oncology NAHOA	Irving	Texas	75063	Recruiting
Cancer Care Center of Brevard	Irving	Texas	75063	Recruiting
Illinois Cancer Specialists	Irving	Texas	75063	Recruiting
Maryland Oncology Hematology	Irving	Texas	75063	Recruiting
Southern Cancer Center	Irving	Texas	75063	Recruiting
Texas Oncology - Northeast Texas	Irving	Texas	75063	Recruiting
Texas Oncology Gulf Coast	Irving	Texas	75063	Recruiting
Texas Oncology McAllen	Irving	Texas	75063	Recruiting
Woodlands Medical	Irving	Texas	75063	Withdrawn
University of Texas Health Science Center San Antonio	San Antonio	Texas	78229	Recruiting
Utah Cancer Specialists	Salt Lake City	Utah	84106	Recruiting
Providence Regional Cancer System	Lacey	Washington	98503	Recruiting
VA Puget Sound Health Care System - VAPSHCS	Seattle	Washington	98108	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Terminated

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 207 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05215340, 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 Jan 6, 2026 · Synced May 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05215340 live on ClinicalTrials.gov.

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