Open Actively Recruiting

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

About

Brief 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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

123 Years

Inclusion Criteria:

Participants at least 18 years of age
Locally advanced 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

Exclusion Criteria:

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 clinically active brain metastases; previously treated brain metastases allowed
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

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