RecruitingPhase 2NCT06363734

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

32 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining osimertinib (a lung cancer targeted therapy) with dalpiciclib (a CDK4/6 inhibitor) can help people with advanced lung cancer whose cancer has a specific EGFR mutation and also has a CDK4/6 pathway abnormality that may cause resistance to standard treatment. **You may be eligible if...** - You have advanced non-small cell lung cancer with an EGFR mutation - Your cancer stopped responding to a third-generation EGFR-targeted drug - Your cancer has an abnormality in the CDK4/6 pathway - You have measurable cancer visible on scans - You have adequate organ function - You have received at least one prior chemotherapy **You may NOT be eligible if...** - You have previously been treated with a CDK4/6 inhibitor - You have active, uncontrolled brain metastases or cancer spreading to the lining of the brain - You have significant unresolved side effects from prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOsimertinib plus Dalpiciclib

osimertinib 80mg daily plus dalpiciclib 125mg daily for 21 days followed by 7 days off in each 28-day treatment cycle


Locations(1)

Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06363734


Related Trials