CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 72 enrolled
Drug / intervention
Trastuzumab deruxtecandrug
Likely dose
Not stated in record
Key inclusion· 6
  • Pathologically documented metastatic non-squamous NSCLC
  • Disease progression on or after at least one prior anticancer treatment line
  • Documented HER2 exon 19 or 20 mutation from central FFPE tumor tissue
  • ECOG performance status 0 or 1
Key exclusion· 5
  • Mixed small cell, squamous, or sarcomatoid histology NSCLC
  • QTcF prolongation >470 ms (females) or >450 ms (males) on screening ECG
  • History of ILD/pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by screening imaging
  • Unresolved toxicities from prior anticancer therapy (Grade >1), except stable chronic Grade 2 with AstraZeneca physician approval

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05246514
NCT05246514Phase 2Active

An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)

AstraZeneca·interventional·Posted Feb 18, 2022·Updated May 12, 2026

In Brief

A Phase 2 clinical trial evaluating Trastuzumab deruxtecan for HER2-mutant Non-Small Cell Lung Cancer. Active but no longer recruiting, targeting 72 participants across 28 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
CollaboratorsDaiichi Sankyo

Timeline

Phase 2ActiveOverdue
2023202420252026
First PostedFeb 18, 2022
Enrollment StartJul 13, 2022
Primary CompletionNov 4, 2024
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.4 years ago

Interventions

Trastuzumab deruxtecandrug

administered as an IV infusion