Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-70
SponsorChina Medical University Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nintedanib, gefitinib, erlotinib, afatinib, osimertinib
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
China Medical University Hospital
Lead sponsor
China Medical University, Taiwan
Collaborator
Source ClinicalTrials.gov