# 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 is a phase 3 interventional study registered as NCT06350097 by AstraZeneca, with 582 participants planned, started 2024-04-29 and due to reach its primary completion in 2028-03-21. Interventions recorded: Osimertinib, Datopotamab Deruxtecan. Conditions listed: Non-small Cell Lung Cancer. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT06350097
- Phase: 3
- Setting: A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Sponsor: AstraZeneca
- Enrolled: 582

## 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/)
- 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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