# TROPION-Lung01

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

## TL;DR

A TROP2 ADC helped in non-squamous lung cancer but not squamous, and the overall survival result fell short.

## Summary

TROPION-Lung01, trial NCT04656652 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, found that the TROP2 antibody-drug conjugate datopotamab deruxtecan helped in previously treated non-squamous non-small-cell lung cancer but not in squamous disease, and that the overall survival result fell short. It randomised 604 patients to datopotamab deruxtecan or docetaxel, met its primary progression-free survival endpoint with a modest effect driven by the non-squamous subgroup, while overall survival, also a primary endpoint, was not significantly different. It led to a narrowed EGFR-mutant approval based on TROPION-Lung05 rather than an all-comers indication, and whether TROP2 ADCs have a place in lung cancer without a driver mutation is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-04
- Registry id: NCT04656652
- Phase: 3
- Setting: Previously treated advanced NSCLC: Dato-DXd vs docetaxel
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 605
- Result: PFS HR 0.75; OS HR 0.94.
- Outcomes: Progression-free survival (BICR): Datopotamab deruxtecan 4.4 months vs Docetaxel 3.7 months, HR 0.75; Overall survival: Datopotamab deruxtecan 12.9 months vs Docetaxel 11.8 months, HR 0.94; Progression-free survival, non-squamous: Datopotamab deruxtecan 5.5 months vs Docetaxel 3.6 months, HR 0.63
- Replication: Mixed result; the approval that followed was narrowed to EGFR-mutant NSCLC on the basis of TROPION-Lung05 (single-arm), not this trial.

## Sources

- ClinicalTrials.gov NCT04656652: https://clinicaltrials.gov/study/NCT04656652

## Connected records

- cancers: [Adenocarcinoma of the lung](https://onco.cc/cancers/lung-adenocarcinoma/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Benjamin Besse](https://onco.cc/people/benjamin-besse/)
- trials: [TROPION-Lung05](https://onco.cc/trials/tropion-lung05/)
- roadmaps: [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/)

---
JSON: https://onco.cc/api/v1/entities/tropion-lung01.json