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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT05048797
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 123 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    Trastuzumab Deruxtecan administered by intravenous infusion
  • Cisplatin — DRUG
    Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
  • Carboplatin — DRUG
    Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
  • Pembrolizumab — DRUG
    Pembrolizumab administered by intravenous infusion
  • Pemetrexed — DRUG
    Pemetrexed administered by intravenous infusion

Study Details

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

Key Dates

Start date
Oct 28, 2021
Status verified
Mar 2026
Primary completion
Apr 30, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
454 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Trastuzumab Deruxtecan (T-DXd)
  • Active Comparator: Arm 2
    Standard of Care Treatment (platinum, pemetrexed and pembrolizumab)

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Until progression or death, assessed up to approximately 12 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90048-
Research SiteOrangeCalifornia92868-
Research SiteSan FranciscoCalifornia94143-
Research SiteSanta MonicaCalifornia90404-
Research SiteSilver SpringMaryland20910-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteBasking RidgeNew Jersey07920-
Research SiteMiddletownNew Jersey07748-
Research SiteMontvaleNew Jersey07645-
Research SiteNew BrunswickNew Jersey08901-
Research SiteCommackNew York11725-
Research SiteHarrisonNew York10604-
Research SiteNew YorkNew York10065-
Research SiteUniondaleNew York11553-
Research SitePittsburghPennsylvania15232-
Research SiteDallasTexas75246-

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