# Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell L

Source: https://onco.cc/trials/nct06350097/  
OnCo record `nct06350097` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Osimertinib, Datopotamab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.

## Summary

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer. ClinicalTrials.gov record last updated 2026-08-26: recruiting. Enrollment is planned at 582 participants. Primary completion is estimated at 2028-03-21. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Osimertinib, Datopotamab Deruxtecan. Registered primary measures: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants..

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-10-06
- Also known as: TROPION-Lung14
- Tags: ctgov-ingest
- Registry id: NCT06350097
- Phase: 3
- Setting: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Sponsor: AstraZeneca
- Enrolled: 582

## Notes

- ClinicalTrials.gov record last updated 2026-08-26: recruiting. Enrollment is planned at 582 participants. Primary completion is estimated at 2028-03-21. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.

## Sources

- ClinicalTrials.gov NCT06350097: https://clinicaltrials.gov/study/NCT06350097

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/), [Osimertinib](https://onco.cc/drugs/osimertinib/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)

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