A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Dato-DXd: Dato-DXd will be administered as IV infusion.
Osimertinib: Osimertinib will be administered orally.
Pemetrexed: Pemetrexed will be administered as IV infusion.
Carboplatin: Carboplatin will be administered as IV infusion.
Cisplatin: Cisplatin will be administered as IV infusion.
Study summary
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Eligibility
Primary outcome measure(s)
- Progression free Survival (PFS) — Up to 2.5 years
PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.
Trial sites (211)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Fayetteville | Arkansas | |
| Research Site | Fountain Valley | California | |
| Research Site | San Diego | California | |
| Research Site | Jacksonville | Florida | |
| Research Site | Kansas City | Missouri | |
| Research Site | New York | New York | |
| Research Site | Maumee | Ohio | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Nashville | Tennessee | |
| Research Site | Fitzroy | Australia | |
| Research Site | Heidelberg | Australia | |
| Research Site | Kogarah | Australia | |
| Research Site | Liverpool | Australia | |
| Research Site | Nedlands | Australia | |
| Research Site | St Leonards | Australia | |
| Research Site | Westmead | Australia | |
| Research Site | Woolloongabba | Australia | |
| Research Site | Charleroi | Belgium | |
| Research Site | Edegem | Belgium | |
| Research Site | Ghent | Belgium | |
| Research Site | Hasselt | Belgium | |
| Research Site | Jette | Belgium | |
| Research Site | Namur | Belgium | |
| Research Site | Roeselare | Belgium | |
| Research Site | Barretos | Brazil | |
| Research Site | Betim | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Brampton | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Québec | Quebec | |
| Research Site | Baoding | China | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China |
+ 171 more sites — see the full list on the official registry below.
On this site
📄 Tagrisso (osimertinib) drug profile →More AstraZeneca trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06417814 on ClinicalTrials.gov ↗ ← All trials in the UK