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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
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

NCT05048797

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

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

Interventions: Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed

Countries: United States, Austria, Belgium, Brazil, Canada, China, Denmark, France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 123 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

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 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
Locations (130)
  • Anchorage, Alaska, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Silver Spring, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Basking Ridge, New Jersey, United States
  • Middletown, New Jersey, United States
  • Montvale, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • Commack, New York, United States
  • Harrison, New York, United States
  • New York, New York, United States
  • Uniondale, New York, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Linz, Austria
  • Vienna, Austria
  • Ghent, Belgium
  • Leuven, Belgium
  • Barretos, Brazil
  • Blumenau, Brazil
  • Brasília, Brazil
  • Natal, Brazil
  • Salvador, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • + 100 more on CT.gov