NCT06363734

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After signing informed consents and completing the screening phase, eligible subjects who meet the enrolment criteria receive the treatment with once-daily osimertinib 80 mg plus dalpiciclib 125 mg daily for 21 consecutive days followed by 7 days off in each 28-day cycle until objective disease progression, intolerable toxicity, or other events that subjects need to be withdrawn from the study.

Conditions

• Non-small Cell Lung Cancer
• EGFR Activating Mutation
• Cell Cycle Deregulation
• EGFR-TKI Resistant Mutation

Interventions

Type	Name	Description
DRUG	Osimertinib plus Dalpiciclib	osimertinib 80mg daily plus dalpiciclib 125mg daily for 21 days followed by 7 days off in each 28-day treatment cycle

Timeline

• Start date: 2024-04-09
• Primary completion: 2025-12-15
• Completion: 2026-12-31
• First posted: 2024-04-12
• Last updated: 2024-04-16

Locations

1 site across 1 country: China