About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

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

Exclusion criteria

1. 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)
2. Any clinically active brain metastases; previously treated brain metastases allowed
3. Active autoimmune or inflammatory disorders
4. Medical history of myocardial infarction within 6 months prior to randomization
5. History of non-infectious pneumonitis/ILD, current or suspected ILD
6. Lung-specific intercurrent clinical significant severe illness
7. Contraindication to platinum-based doublet chemotherapy or pembrolizumab

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.