Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Oct 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two treatments, Nintedanib and EGFR-TKI, for patients with advanced non-small cell lung cancer (NSCLC) that has become resistant to previous treatments. The goal is to see how effective and safe this combination is for patients who have specific genetic changes called EGFR mutations and have not responded to first-line therapies. The trial is currently looking for participants aged 20 to 70 who have been diagnosed with advanced stages of this type of lung cancer.

To be eligible for the study, participants need to have confirmed EGFR mutations and have already tried certain medications (like gefitinib or erlotinib) without success. They should also have good functioning organs, specifically their liver, kidneys, and bone marrow. Unfortunately, individuals with serious side effects from previous treatments, known high blood pressure, liver or gastrointestinal diseases, or brain metastasis (spread of cancer to the brain) cannot participate. The trial is a chance for patients to help researchers learn more about new treatment options that could potentially improve their outcomes. If you or someone you know fits these criteria, participating in this trial could be an important step in exploring new ways to fight this challenging disease.

Gender

ALL

Eligibility criteria

• 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).