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Clinical Trial ● Currently Recruiting Phase III NCT06417814

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

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…

📅 14 May 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06417814
Sponsor
AstraZeneca
Start
2024-10-04
ClinicaliQ Trial Snapshot
  • 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 — Recruiting • Phase III • Oncology • NCT06417814.
  • What is being tested: Dato-DXd (a novel antibody-drug conjugate) as monotherapy or combined with osimertinib versus standard platinum-based chemotherapy, with primary endpoint of progression-free survival in EGFR-mutated advanced lung cancer.
  • Patient eligibility overview: Adults with EGFR-mutated locally advanced or metastatic non-small cell lung cancer, representing a treatment-Phase IIIïve or previously treated population meeting specific molecular and disease stage criteria.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • : * Histologically or cytologically confirmed non-squamous NSCLC. * Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M). * Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting. * Less than or equal to (

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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