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

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas 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 8 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

Trial Details

NCT ID
NCT06350097
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Osimertinib
  • Datopotamab Deruxtecan
Locations (sample)
  • Fountain Valley, California, United States|33.70918,-117.95367
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Participant must be ≥ 18 years.
  • Type of Participant and Disease Characteristics
  • Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed if adenocarcinoma is the predominant histology. M…
  • Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to cura…

For full eligibility, visit ClinicalTrials.gov.

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