Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Recruiting · NCT06071013 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Nintedanib, gefitinib, erlotinib, afatinib, osimertinib
What this trial is about
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
Who can take part
Age range
20 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed.
- China Medical University Hospital - Taichung, Taiwan