NCT05048797

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 123 Years
• Healthy volunteers: Not accepted

Summary

DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

Detailed description

Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease. The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Conditions

• Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Deruxtecan	Trastuzumab Deruxtecan administered by intravenous infusion
DRUG	Cisplatin	Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
DRUG	Carboplatin	Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
DRUG	Pembrolizumab	Pembrolizumab administered by intravenous infusion
DRUG	Pemetrexed	Pemetrexed administered by intravenous infusion

Timeline

• Start date: 2021-10-28
• Primary completion: 2026-04-30
• Completion: 2027-07-30
• First posted: 2021-09-17
• Last updated: 2026-04-03

Locations

130 sites across 20 countries: United States, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study