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
No
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

Join this Trial

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Study Stats
Protocol No.
22-000067
Category
Hematology-Oncology
Oncology
Contact
CINDY TONG
Location
  • UCLA Alhambra
  • UCLA Pasadena
  • UCLA Santa Monica
For Providers
NCT No.
NCT05048797
For detailed technical eligibility, visit ClinicalTrials.gov.