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

Description

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

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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

An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

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

Condition
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Anchorage

Research Site, Anchorage, Alaska, United States, 99508

Los Alamitos

Research Site, Los Alamitos, California, United States, 90720

Los Angeles

Research Site, Los Angeles, California, United States, 90048

Orange

Research Site, Orange, California, United States, 92868

San Francisco

Research Site, San Francisco, California, United States, 94143

Santa Monica

Research Site, Santa Monica, California, United States, 90404

Santa Rosa

Research Site, Santa Rosa, California, United States, 95403

Silver Spring

Research Site, Silver Spring, Maryland, United States, 20910

Boston

Research Site, Boston, Massachusetts, United States, 02118

Boston

Research Site, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 123 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-03-29