Trials / Recruiting
RecruitingNCT07291037
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
TROPION-Lung17 is a phase III, 2-arm, randomised, open-label, multicentre study, assessing the efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), and to assess the clinical performance of the investigational in vitro diagnostic (IVD) device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Datopotamab deruxtecan (Dato-DXd) | Dato-DXd administered intravenously (IV) |
| DRUG | Docetaxel | Docetaxel administered intravenously (IV) |
Timeline
- Start date
- 2025-10-31
- Primary completion
- 2029-01-29
- Completion
- 2029-01-29
- First posted
- 2025-12-18
- Last updated
- 2026-03-20
Locations
198 sites across 20 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Germany, Hungary, India, Italy, Japan, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07291037. Inclusion in this directory is not an endorsement.