NCT05246514Active, not recruitingPhase 2
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
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)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 11 Feb 2022
- Start date
- 13 Jul 2022
- Primary completion date
- 4 Nov 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT05246514
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 72
- From 13 Jul 2022 to the primary completion date, 4 Nov 2024
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
- Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
Other illness
- Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Lab values
- Corrected QT interval (QTcF) prolongation to \> 470 ms (females) or \> 450 ms (males), based on average of the screening triplicate 12-lead ECG.
Who the study is looking for
- Pathologically documented metastatic non-squamous NSCLC.
- Has relapsed from or is refractory to at least one-line of anticancer treatment.
- Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
- WHO or ECOG performance status of 0 or 1.
- Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
- LVEF ≥ 50% within 28 days before enrolment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.