Nintedanib, 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.
Study 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
Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
2. Positive EGFR mutations are diagenesis.
3. Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.
4. Participants must have adequate hepatic, renal, and bone marrow function
Exclusion Criteria:
1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
2. Participants have known hypertension, and chronic liver and gastrointestinal disease.
3. Participants have known brain metastasis.
4. Female participants who are pregnant or breast-feeding
5. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
Primary outcome measure(s)
The toxicity of combinate nintedanib and EGFR TKI — Assessed every 6 weeks of chest CT scan until PD.
Patient objective response rate — Assessed every 6 weeks of chest CT scan
Trial sites (1)
Facility
City
Region
Status
China Medical University Hospital
Taichung
Taiwan
Recruiting
More China Medical University Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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