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 - Trial NCT06350097
Access comprehensive clinical trial information for NCT06350097 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Non-small Cell Lung Cancer. Target enrollment is 582 participants.
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Study Focus
Sponsor & Location
AstraZeneca
Timeline & Enrollment
Phase 3
May 16, 2024
May 25, 2032
Primary Outcome
To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants.
Summary
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in
 combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet)
 monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm
 (Ex19del and/or L858R) NSCLC.
 
 Study details include:
 
 1. The study duration will be event-driven, with an estimated duration of approximately 9
 years.
 
 2. Participants may receive study treatment until disease progression, unacceptable
 toxicity, or other specific discontinuation criteria are met.
 
 3. The visit frequency will be every 3 weeks during the treatment period.
 
 Note: Participants on osimertinib treatment (osimertinib only arm or who have discontinued
 Datopotamab Deruxtecan while are still receiving osimertinib) are required to attend visits
 to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12
 weeks until disease progression, IP discontinuation or primary PFS DCO. Participants who are
 receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform
 assessment every 3 weeks (q3w) per SoA.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06350097
Non-Device Trial