A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Chih-Yen Tu
chesttu@gmail.com
+886-975-681-007
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2026-08-27
Participants
Target number of participants: 20
Treatments
Experimental: Nintedanib + gefitinib/erlotinib/afatinib/osimertinib
Nintedanib will administered orally twice per day Gefitinib will administered orally once daily Erlotinib will administered orally once daily Afatinib will administered orally once daily Osimertinib will administered orally once daily
Related Therapeutic Areas
Sponsors
Collaborators: China Medical University, Taiwan
Leads: China Medical University Hospital