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

Running, not enrolling · Phase 3

Conditions studied: Locally Advanced or Metastatic Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT05048797

Run by

AstraZeneca

People needed

454

Starts

2021-10-28

Expected to finish

2027-07-30

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 123. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants at least 18 years of age
• Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
• Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
• Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Measurable disease assessed by Investigator based on RECIST 1.1
• Protocol-defined adequate organ function including cardiac, renal, hepatic function
• ECOG 0-1
• Having tumour tissue available for central testing

You may not qualify if…

• Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
• Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
• Active autoimmune or inflammatory disorders
• Medical history of myocardial infarction within 6 months prior to randomization
• History of non-infectious pneumonitis/ILD, current or suspected ILD
• Lung-specific intercurrent clinical significant severe illness
• Contraindication to platinum-based doublet chemotherapy or pembrolizumab

Where it is running

• Research Site — Los Alamitos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Silver Spring, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Basking Ridge, New Jersey, United States
• Research Site — Middletown, New Jersey, United States
• Research Site — Montvale, New Jersey, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Commack, New York, United States
• Research Site — Harrison, New York, United States
• Research Site — New York, New York, United States
• Research Site — Uniondale, New York, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Linz, Austria
• Research Site — Vienna, Austria
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Barretos, Brazil
• Research Site — Blumenau, Brazil
• Research Site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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