A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
Public ClinicalTrials.gov record NCT06564844. 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 Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Study identification
- NCT ID
- NCT06564844
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Interventions
- Datopotamab Deruxtecan Drug
- Rilvegostomig Drug
- Carboplatin Drug
- Cisplatin Drug
- Etoposide Drug
- Pemetrexed Drug
- Vinorelbine Drug
- UFT 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
- Oct 15, 2024 (Actual)
- Primary completion
- Jul 10, 2026 (Actual)
- Completion
- Mar 31, 2027 (Estimated)
- Last update posted
- Sep 23, 2026
2024 – 2027
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85724 | — |
| Research Site | Duarte | California | 91010 | — |
| Research Site | Glendale | California | 91204 | — |
| Research Site | Los Angeles | California | 90089 | — |
| Research Site | Lone Tree | Colorado | 80124 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Jacksonville | Florida | 32224 | — |
| Research Site | St. Petersburg | Florida | 33709 | — |
| Research Site | Chicago | Illinois | 60637 | — |
| Research Site | Evanston | Illinois | 60201 | — |
| Research Site | Zion | Illinois | 60099 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Lexington | Kentucky | 40503 | — |
| Research Site | Baltimore | Maryland | 21237 | — |
| Research Site | Farmington Hills | Michigan | 48334 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | Minneapolis | Minnesota | 55407 | — |
| Research Site | Billings | Montana | 59102 | — |
| Research Site | Omaha | Nebraska | 68130 | — |
| Research Site | East Syracuse | New York | 13057 | — |
| Research Site | Mineola | New York | 11501 | — |
| Research Site | New York | New York | 10016 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Bethlehem | Pennsylvania | 18015 | — |
| Research Site | Philadelphia | Pennsylvania | 19107 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Knoxville | Tennessee | 37920 | — |
| Research Site | Memphis | Tennessee | 38120 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Austin | Texas | 78745 | — |
| Research Site | Dallas | Texas | 75231 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | San Antonio | Texas | 78217 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Seattle | Washington | 98104 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06564844, 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 23, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06564844 live on ClinicalTrials.gov.