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NCT05048797 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
454
Enrollment target
20
Study locations

NCT05048797: Active Phase 3 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, sponsored by AstraZeneca.

NCT05048797 is a Phase 3 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05048797, a Phase 3 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
454 participants
Enrollment target
20
Study locations

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

Primary Outcome

Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.

Conditions Studied

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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
AstraZeneca

1,285 total trials

What the registry record for NCT05048797 still lists

NCT05048797 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).

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.

NCT05048797 names 20 study sites across 10 states, led by California, New Jersey, New York.

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.

What interventions are being tested in trial NCT05048797?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Trastuzumab Deruxtecan (DRUG).

Who is sponsoring clinical trial NCT05048797?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05048797's enrollment target sits among peer trials

454 832nd of 2000 higher than 1,167 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05048797, the US trial registry maintained by the National Library of Medicine. NCT05048797 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.