CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 605 enrolled
Drug / intervention
DS-1062a +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04656652
NCT04656652Phase 3Active

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

Daiichi Sankyo·interventional·Posted Dec 7, 2020·Updated Mar 24, 2026

In Brief

A Phase 3 clinical trial evaluating DS-1062a and Docetaxel for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 605 participants across 209 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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, United States
CollaboratorsAstraZeneca

Timeline

Phase 3Active
2021202220232024202520262027
First PostedDec 7, 2020
Enrollment StartDec 21, 2020
Primary CompletionMay 10, 2024
Study CompletionFeb 15, 2027
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.6 years ago

Interventions

DS-1062adrug

DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle

Docetaxeldrug

Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.