Phase III Study Comparing Osimertinib With or Without Datopotamab Deruxtecan for First-line Treatment of EGFR Mutation-Positive Advanced or Metastatic Non-small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining osimertinib tablets with Datopotamab Deruxtecan intravenous infusion compared to using osimertinib tablets alone as a first treatment for participants with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific EGFR mutations Ex19del andor L858R. This global Phase III, open-label, randomized study targets participants who have not yet received treatment for advanced disease and aims to assess how well this combination works and how safe it is over an estimated 8-year event-driven study duration. Participants will be randomly assigned to one of two groups one will receive osimertinib 80 mg orally once daily combined with Datopotamab Deruxtecan 6 mgkg by intravenous infusion every three weeks, while the other will receive osimertinib 80 mg orally once daily alone. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During treatment, visits occur every three weeks. For those receiving osimertinib alone or who stop Datopotamab Deruxtecan but remain on osimertinib, visits become every six weeks from cycle 7 to cycle 17 and then every twelve weeks until disease progression or stopping treatment. Participants will undergo regular assessments including scans and tests to monitor disease status and treatment effects as per the study schedule. Researchers will measure progression-free survival, overall survival, response rates, and other outcomes related to the cancer and treatment effects. Safety and drug levels will also be monitored. Participants can expect frequent visits and evaluations throughout the study, lasting up to about eight years or until specific stopping criteria are met.

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