A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients with HER2 Mutant NSCLC - DL-05

Study identifier:D7811C00001

ClinicalTrials.gov identifier:NCT05246514

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients with HER2-mutant Metastatic NSCLC who have Disease Progression on or after at Least One-line of Treatment (DESTINY-Lung05)

Medical condition

HER2-mutant Non-Small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan

Sex

All

Actual Enrollment

72

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 13 Jul 2022
Primary Completion Date: 23 Sept 2023
Estimated Study Completion Date: 24 Jun 2024

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria