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Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
RECRUITINGPhase 1/2Sponsored by China Medical University Hospital
Actively Recruiting
PhasePhase 1/2
SponsorChina Medical University Hospital
Started2024-02-23
Est. completion2026-08-27
Eligibility
Age20 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06071013
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
Age: 20 Years – 70 YearsHealthy volunteers accepted
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).
Conditions5
CancerEGFR Gene MutationEGFR-TKI Resistant MutationLung CancerNon Small Cell Lung Cancer
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Actively Recruiting
PhasePhase 1/2
SponsorChina Medical University Hospital
Started2024-02-23
Est. completion2026-08-27
Eligibility
Age20 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06071013