RecruitingPhase 1Phase 2NCT06071013

Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients


Sponsor

China Medical University Hospital

Enrollment

20 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer


Eligibility

Min Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding nintedanib — a drug that targets tumor blood vessel growth — to a standard targeted lung cancer drug (EGFR inhibitor) can help patients whose advanced non-small cell lung cancer has stopped responding to first-line EGFR therapy. **You may be eligible if...** - You are between 20 and 70 years old - You have advanced non-small cell lung cancer (stage III or IV) with an EGFR mutation - Your cancer has stopped responding to a first-generation EGFR drug (gefitinib, erlotinib, afatinib, or osimertinib) - Your lung, liver, kidney, and bone marrow function are adequate **You may NOT be eligible if...** - You have received more than one prior EGFR therapy - You have serious liver, kidney, or heart problems - You are pregnant or breastfeeding - You have uncontrolled brain metastases 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.

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Interventions

DRUGNintedanib, gefitinib, erlotinib, afatinib, osimertinib

Nintedanib is a multiple tyrosine kinase inhibitor that can bind competitively to the ATP-binding pocket of these receptors and block intracellular signaling, which is critical for the proliferation and migration. Gefitinib, erlotinib and afatinib are the first- and second- generation of EGFR tyrosine kinase inhibitors that reversibly and irreversibly inhibit the binding of ATP to the phosphate-binding loop of ATP binding site in the kinase domain of EGFR, leading to the inhibition of cell proliferation and induction of apoptosis of cancer cells.


Locations(1)

China Medical University Hospital

Taichung, Taiwan

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NCT06071013


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