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Clinical Trial 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.


Clinical Trial 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each 28-day cycle until objective disease progression, intolerable toxicity, or other events that subjects need to be withdrawn from the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06363734
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact
Status Recruiting
Phase Phase 2
Start date April 9, 2024
Completion date December 31, 2026

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