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

ClinicalTrials.gov ID: NCT05048797

Public ClinicalTrials.gov record NCT05048797. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT05048797
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 454 participants

Conditions and interventions

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 123 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 28, 2021 (Actual)
Primary completion: Jun 9, 2026 (Actual)
Completion: Jul 30, 2027 (Estimated)
Last update posted: Jul 10, 2026

2021 – 2027

United States locations

U.S. sites: 19
U.S. states: 9
U.S. cities: 19

Facility	City	State	ZIP	Site status
Research Site	Anchorage	Alaska	99508	—
Research Site	Los Alamitos	California	90720	—
Research Site	Los Angeles	California	90048	—
Research Site	Orange	California	92868	—
Research Site	San Francisco	California	94143	—
Research Site	Santa Monica	California	90404	—
Research Site	Silver Spring	Maryland	20910	—
Research Site	Boston	Massachusetts	02215	—
Research Site	Ann Arbor	Michigan	48109	—
Research Site	Basking Ridge	New Jersey	07920	—
Research Site	Middletown	New Jersey	07748	—
Research Site	Montvale	New Jersey	07645	—
Research Site	New Brunswick	New Jersey	08901	—
Research Site	Commack	New York	11725	—
Research Site	Harrison	New York	10604	—
Research Site	New York	New York	10065	—
Research Site	Uniondale	New York	11553	—
Research Site	Pittsburgh	Pennsylvania	15232	—
Research Site	Dallas	Texas	75246	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 111 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05048797, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 10, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05048797 live on ClinicalTrials.gov.

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