NCT04656652

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) with or without actionable genomic alterations.

Detailed description

This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m\^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations (AGAs). Participants without actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable genomic alteration. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DS-1062a	DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
DRUG	Docetaxel	Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.

Timeline

• Start date: 2020-12-21
• Primary completion: 2024-05-10
• Completion: 2027-02-15
• First posted: 2020-12-07
• Last updated: 2026-03-24
• Results posted: 2025-07-23

Locations

209 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study