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ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG Pembrolizumab
  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • DRUG Trastuzumab Deruxtecan

Study Locations (20)

California

  • Research Site — Los Alamitos
  • Research Site — Los Angeles
  • Research Site — Orange
  • Research Site — San Francisco
  • Research Site — Santa Monica

New Jersey

  • Research Site — Basking Ridge
  • Research Site — Middletown
  • Research Site — Montvale
  • Research Site — New Brunswick

New York

  • Research Site — Commack
  • Research Site — Harrison
  • Research Site — New York
  • Research Site — Uniondale

Alaska

  • Research Site — Anchorage

Maryland

  • Research Site — Silver Spring

Massachusetts

  • Research Site — Boston

Michigan

  • Research Site — Ann Arbor

Pennsylvania

  • Research Site — Pittsburgh

Trial Details

FieldValue
Enrollment Target 454 participants
Start Date 2021-10-28
Est. Completion 2027-07-30
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05048797

The ClinicalTrials.gov registry entry for NCT05048797 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 454 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Locally Advanced or Metastatic Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05048797 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05048797 about?

NCT05048797 is a clinical study titled "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". 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

What is the current status of trial NCT05048797?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2021-10-28. Estimated completion is 2027-07-30.

What conditions does trial NCT05048797 study?

This clinical trial studies the following conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05048797?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Trastuzumab Deruxtecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05048797?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05048797 being conducted?

This trial has 20 study locations across Alaska, California, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial