Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- AstraZeneca
- Study ID
- NCT07291037
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Datopotamab deruxtecan (Dato-DXd) — DRUGDato-DXd administered intravenously (IV)
- Docetaxel — DRUGDocetaxel administered intravenously (IV)
Study Details
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
Key Dates
- Start date
- Oct 31, 2025
- Status verified
- May 2026
- Primary completion
- Jan 29, 2029
- Completion
- Jan 29, 2029
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapyParticipants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
- Active Comparator: Arm B: Docetaxel monotherapyParticipants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: Approximately 2.5 years ]
Central Contacts
- AstraZeneca Clinical Study Information Center1-877-240-9479
Locations (50)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | - |
| Research Site | Gilbert | Arizona | 85234 | - |
| Research Site | Goodyear | Arizona | 85338 | - |
| Research Site | Duarte | California | 91010 | - |
| Research Site | Irvine | California | 92618 | - |
| Research Site | La Jolla | California | 92093 | - |
| Research Site | Loma Linda | California | 92350 | - |
| Research Site | Los Angeles | California | 90095 | - |
| Research Site | San Diego | California | 92123 | - |
| Research Site | Grand Junction | Colorado | 81501 | - |
| Research Site | Wheat Ridge | Colorado | 80033 | - |
| Research Site | Newark | Delaware | 19713 | - |
| Research Site | Washington D.C. | District of Columbia | 20037 | - |
| Research Site | Fort Myers | Florida | 33901 | - |
| Research Site | Jacksonville | Florida | 32224 | - |
| Research Site | St. Petersburg | Florida | 33709 | - |
| Research Site | Tampa | Florida | 33612 | - |
| Research Site | West Palm Beach | Florida | 33401 | - |
| Research Site | Marietta | Georgia | 30060 | - |
| Research Site | Newnan | Georgia | 30265 | - |
| Research Site | Chicago | Illinois | 60612 | - |
| Research Site | Chicago | Illinois | 60637 | - |
| Research Site | Niles | Illinois | 60714 | - |
| Research Site | Zion | Illinois | 60099 | - |
| Research Site | Louisville | Kentucky | 40207 | - |
| Research Site | South Portland | Maine | 04106 | - |
| Research Site | Baltimore | Maryland | 21201 | - |
| Research Site | Brandywine | Maryland | 20613 | - |
| Research Site | Boston | Massachusetts | 02215 | - |
| Research Site | Detroit | Michigan | 48202 | - |
| Research Site | Rochester | Minnesota | 55905 | - |
| Research Site | Bridgeton | Missouri | 63044 | - |
| Research Site | Columbia | Missouri | 65212 | - |
| Research Site | Lincoln | Nebraska | 68516 | - |
| Research Site | Albuquerque | New Mexico | 87109 | - |
| Research Site | East Syracuse | New York | 13057 | - |
| Research Site | Portland | Oregon | 97239 | - |
| Research Site | Hershey | Pennsylvania | 17033 | - |
| Research Site | Philadelphia | Pennsylvania | 19104 | - |
| Research Site | Greenville | South Carolina | 29607 | - |
| Research Site | Memphis | Tennessee | 38120 | - |
| Research Site | Austin | Texas | 78745 | - |
| Research Site | Denton | Texas | 76201 | - |
| Research Site | Plano | Texas | 75075 | - |
| Research Site | Charlottesville | Virginia | 22908 | - |
| Research Site | Fairfax | Virginia | 22031 | - |
| Research Site | Williamsburg | Virginia | 23188 | - |
| Research Site | Tacoma | Washington | 98405 | - |
| Research Site | Morgantown | West Virginia | 26506 | - |
| Research Site | Eau Claire | Wisconsin | 54703 | - |
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