Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)
Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
Detailed Description:
This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m2 in participants with advanced or metastatic NSCLC without actionable genomic alterations and who have been previously treated with platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody, either in combination or sequentially. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)
Actual Study Start Date: December 21, 2020
Estimated Primary Completion Date: October 27, 2022
Estimated Study Completion Date: June 27, 2024
Arm:
- Experimental: DS-1062a 6.0 mg/kg
- Active Comparator: Docetaxel 75 mg/m2
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 590 |
| Actual Study start date | 21 December 2020 |
| Estimated Study Completion Date | 27 June 2024 |