Clinical Trial

Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial

Recruiting Phase 2
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Record status
This record was last updated April 16, 2024 (before its estimated December 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-09; most recent amendment 2024-04-14.
Trial Details
NCT Number NCT06363734
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Non-small Cell Lung Cancer, EGFR Activating Mutation, Cell Cycle Deregulation, EGFR-TKI Resistant Mutation
Enrollment 32 participants
Start Date 2024-04-09
Primary Completion 2025-12-15 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-04-16