A study to investigate the efficacy and safety of trastuzumab deruxtecan as the first treatment option for unresectable, locally advanced/metastatic Non-Small Cell Lung Cancer with HER2 mutations

Study identifier:D967SC00001

ClinicalTrials.gov identifier:NCT05048797

EudraCT identifier:2021-000634-33

CTIS identifier:N/A

Recruiting

Official Title

An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

Medical condition

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed

Sex

All

Estimated Enrollment

450

Study type

Interventional

Age

18 Years - 123 Years

Date

Study Start Date: 28 Oct 2021
Estimated Primary Completion Date: 30 Jun 2025
Estimated Study Completion Date: 29 Mar 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria