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
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Study identification
- NCT ID
- NCT05215340
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 740 participants
Conditions and interventions
Conditions
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 4, 2022 (Actual)
- Primary completion
- Mar 4, 2030 (Estimated)
- Completion
- Mar 4, 2032 (Estimated)
- Last update posted
- Sep 24, 2026
2022 – 2032
United States locations
- U.S. sites
- 31
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | — |
| UCLA HemOnc - Clinical Research Unit | Los Angeles | California | 90095 | — |
| Ridley-Tree Cancer Center | Santa Barbara | California | 93105 | — |
| PIH Health Whittier Hospital | Whittier | California | 90602 | — |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90603 | — |
| Uch-Mhs D/B/A Memorial Health System | Colorado Springs | Colorado | 80909 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| American Oncology Partners of Maryland | Bethesda | Maryland | 20817 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute - Foxborough | Foxborough | Massachusetts | 02035 | — |
| DFCI - South Shore Hospital | South Weymouth | Massachusetts | 02190 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | — |
| Regional Cancer Care Associates LLC | Freehold | New Jersey | 07728 | — |
| Cooperman Barnabas Medical Center | New Brunswick | New Jersey | 08901 | — |
| The Valley Hospital | Paramus | New Jersey | 07652 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Arizona Oncology NAHOA | Irving | Texas | 75063 | — |
| Cancer Care Center of Brevard | Irving | Texas | 75063 | — |
| Illinois Cancer Specialists | Irving | Texas | 75063 | — |
| Maryland Oncology Hematology | Irving | Texas | 75063 | — |
| Southern Cancer Center | Irving | Texas | 75063 | — |
| Texas Oncology - Northeast Texas | Irving | Texas | 75063 | — |
| Texas Oncology Gulf Coast | Irving | Texas | 75063 | — |
| Texas Oncology McAllen | Irving | Texas | 75063 | — |
| University of Texas Health Science Center San Antonio | San Antonio | Texas | 78229 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Providence Regional Cancer System | Lacey | Washington | 98503 | — |
| VA Puget Sound Health Care System - VAPSHCS | Seattle | Washington | 98108 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 203 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 Sep 24, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05215340 live on ClinicalTrials.gov.