# DESTINY-Lung01

Source: https://onco.cc/trials/destiny-lung01/  
OnCo record `destiny-lung01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

DESTINY-Lung01 showed that the antibody-drug conjugate trastuzumab deruxtecan shrank tumours in more than half of people whose lung cancer carried a HER2 mutation, which led to the first approved HER2-targeted treatment for lung cancer.

## Summary

DESTINY-Lung01 was a two-cohort phase 2 study of trastuzumab deruxtecan, an antibody-drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells, in metastatic non-small-cell lung cancer that had progressed on standard therapy. One cohort enrolled HER2-mutant tumours and the other HER2-overexpressing tumours.

In the HER2-mutant cohort the drug produced responses in a majority of patients with durable disease control, including in the brain. Interstitial lung disease was the toxicity that needed monitoring. The result led to accelerated approval in the United States in August 2022 for HER2-mutant non-small-cell lung cancer after prior systemic therapy, the first HER2-directed approval in lung cancer. The HER2-overexpressing cohort showed lower activity.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT03505710
- Phase: 2
- Setting: Previously treated HER2-mutant or HER2-overexpressing metastatic non-small-cell lung cancer: single-arm trastuzumab deruxtecan
- Sponsor: Daiichi Sankyo
- Enrolled: 181
- Result: High response rate with durable responses in HER2-mutant non-small-cell lung cancer; accelerated approval in August 2022.

## Sources

- ClinicalTrials.gov NCT03505710: https://clinicaltrials.gov/study/NCT03505710

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Bob T. Li](https://onco.cc/people/bob-li/)
- key papers: [DESTINY-Lung01: trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer](https://onco.cc/key-papers/paper-destiny-lung01-nejm-2022/)

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