Status:
RECRUITING
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
China Medical University, Taiwan
Conditions:
Non-small Cell Lung Cancer
EGFR Gene Mutation
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
Brief 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
Detailed Description
The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival. Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is ef...
Eligibility Criteria
Inclusion
- Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
- Positive EGFR mutations are diagenesis.
- 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.
- Participants must have adequate hepatic, renal, and bone marrow function
Exclusion
- Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
- Participants have known hypertension, and chronic liver and gastrointestinal disease.
- Participants have known brain metastasis.
- Female participants who are pregnant or breast-feeding
- Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
Key Trial Info
Start Date :
February 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 27 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06071013
Start Date
February 23 2024
End Date
August 27 2026
Last Update
January 23 2025
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan