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
Condition(s) studied
Investigational drug(s) / intervention(s)
Trastuzumab Deruxtecan: Trastuzumab Deruxtecan administered by intravenous infusion
Cisplatin: Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
Carboplatin: Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
Pembrolizumab: Pembrolizumab administered by intravenous infusion
Pemetrexed: Pemetrexed administered by intravenous infusion
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
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) — Until progression or death, assessed up to approximately 12 months
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.
Trial sites (130)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Anchorage | Alaska | |
| Research Site | Los Alamitos | California | |
| Research Site | Los Angeles | California | |
| Research Site | Orange | California | |
| Research Site | San Francisco | California | |
| Research Site | Santa Monica | California | |
| Research Site | Silver Spring | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Basking Ridge | New Jersey | |
| Research Site | Middletown | New Jersey | |
| Research Site | Montvale | New Jersey | |
| Research Site | New Brunswick | New Jersey | |
| Research Site | Commack | New York | |
| Research Site | Harrison | New York | |
| Research Site | New York | New York | |
| Research Site | Uniondale | New York | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Dallas | Texas | |
| Research Site | Linz | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Ghent | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Barretos | Brazil | |
| Research Site | Blumenau | Brazil | |
| Research Site | Brasília | Brazil | |
| Research Site | Natal | Brazil | |
| Research Site | Salvador | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Uberlândia | Brazil | |
| Research Site | Vancouver | British Columbia | |
| Research Site | Brampton | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Changchun | China | |
| Research Site | Changsha | China | |
| Research Site | Changsha | China |
+ 90 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile → 📄 Keytruda (pembrolizumab) drug profile →More AstraZeneca trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05048797 on ClinicalTrials.gov ↗ ← All trials in Spain