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DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

NCT03505710 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2025-05-30

Study results available
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Summary

The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan

Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

Sponsors & Collaborators

Principal Investigators

  • Global Team Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-05-03
Completion
2024-04-17
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505710 on ClinicalTrials.gov