Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance on Third-generation EGFR TKI： a Single-arm Phase II Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• ECOG performance status 0 to 2 with a minimum life expectancy of 12 weeks
• Advanced non-small cell lung cancer with EGFR-sensitive mutation
• Confirmed medical history of acquired resistance to third-generation EGFR TKI
• Concurrent CDK4/6 pathway gene dysfunctional aberrations
• Evaluable or measurable disease as defined by RECIST, Version 1.1
• At least one prior line of systemic chemotherapy
• Adequate organ function
Locations
Other Locations
China
Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital
RECRUITING
Tianjin
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 32
Treatments
Experimental: osimertinib in combination with dalpiciclib
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital