ACTIVE_NOT_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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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)

Quick Facts

Study Start:2021-10-28
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05048797

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.

Ages Eligible for Study:18 Years to 123 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants at least 18 years of age
  2. * Locally advanced and unresectable NSCLC, 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
  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 untreated brain metastases, including asymptomatic or clinically inactive brain metastases
  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

Contacts and Locations

Study Locations (Sites)

Research Site
Anchorage, Alaska, 99508
United States
Research Site
Los Alamitos, California, 90720
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Orange, California, 92868
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Santa Monica, California, 90404
United States
Research Site
Silver Spring, Maryland, 20910
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Basking Ridge, New Jersey, 07920
United States
Research Site
Middletown, New Jersey, 07748
United States
Research Site
Montvale, New Jersey, 07645
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
Commack, New York, 11725
United States
Research Site
Harrison, New York, 10604
United States
Research Site
New York, New York, 10065
United States
Research Site
Uniondale, New York, 11553
United States
Research Site
Pittsburgh, Pennsylvania, 15232
United States
Research Site
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-28
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2021-10-28
Study Completion Date2027-07-30

Terms related to this study

Keywords Provided by Researchers

  • DS-8201a
  • HER2 exon 19 or 20 mutations
  • ERBB2 gene (coding for the HER2 protein)
  • T-DXd
  • Trastuzumab Deruxtecan
  • Locally advanced and unresectable non-squamous NSCLC
  • Metastatic non-squamous NSCLC
  • Non-small cell lung cancer

Additional Relevant MeSH Terms

  • Locally Advanced or Metastatic Non-Small Cell Lung Cancer