At a glance
ClinicalIndex Comparison RecordPhase 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.
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)
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--
ConditionsHER2-mutant Non-Small Cell Lung Cancer
CountriesChina
CollaboratorsDaiichi Sankyo
Timeline
Phase 2ActiveOverdue
2023202420252026
First PostedFeb 2022
Enrollment StartJul 2022
Primary CompletionNov 2024
Study CompletionJun 2026
TodayJul 2026
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