NCT04484142

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

Detailed description

This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC with actionable genomic alterations and who have been previously been treated with 1 platinum-containing therapy and 1 or more lines of targeted therapy. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will be conducted after all participants either have been followed for at least 9 months after the start of study treatment or have discontinued from the study, whichever occurs first.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DS-1062a	DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-03-10
• Completion: 2026-02-04
• First posted: 2020-07-23
• Last updated: 2026-03-24
• Results posted: 2024-04-03

Locations

84 sites across 10 countries: United States, France, Germany, Hungary, Italy, Japan, Netherlands, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study