# TROPION-Lung05

Source: https://onco.cc/trials/tropion-lung05/  
OnCo record `tropion-lung05` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The study that got Datroway approved for EGFR-mutant lung cancer after other treatments fail.

## Summary

TROPION-Lung05, trial NCT04484142 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the phase 2 study that supported approval of datopotamab deruxtecan for EGFR-mutant non-small-cell lung cancer after targeted therapy and platinum chemotherapy have failed. It enrolled 137 patients with actionable genomic alterations in a single-arm design, the objective response rate by blinded review was higher in the 78 EGFR-mutant patients than overall, and pooled with EGFR-mutant patients from TROPION-Lung01 the data supported accelerated approval in June 2025. OnCo links it to TROP2 and EGFR as targets and to TROPION-Lung01. As a single-arm phase 2 it cannot show that the drug improves survival over the alternatives, and the randomised TROPION-Lung15 trial will be the confirmatory study. Datopotamab deruxtecan has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT04484142
- Phase: 2
- Setting: Actionable-genomic-alteration NSCLC after targeted therapy and platinum: datopotamab deruxtecan single arm
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 137
- Result: ORR 43.6% in EGFR-mutant disease.
- Outcomes: Objective response rate (BICR): Datopotamab deruxtecan, all 35.8% vs EGFR-mutant subgroup 43.6%
- Replication: Single-arm phase 2 that supported the EGFR-mutant NSCLC approval; TROPION-Lung15 (randomised) will be the confirmatory trial.

## Sources

- ClinicalTrials.gov NCT04484142: https://clinicaltrials.gov/study/NCT04484142

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- trials: [TROPION-Lung01](https://onco.cc/trials/tropion-lung01/)
- key papers: [Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study](https://onco.cc/key-papers/paper-tropion-lung05-j-clin-oncol-2025/)

---
JSON: https://onco.cc/api/v1/entities/tropion-lung05.json