Study of Nintedanib Plus EGFR Tyrosine Kinase Inhibitors for EGFR-Mutated Non-Small Cell Lung Cancer A Phase I/II Trial Evaluating Treatment in Patients Resistant to EGFR-TKI Therapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Nintedanib with EGFR tyrosine kinase inhibitors (EGFR-TKI) in adults aged 20 to 70 years who have advanced non-small cell lung cancer (NSCLC) that is resistant to EGFR-TKI treatment. This study focuses on participants with specific EGFR gene mutations and aims to measure progression-free survival and overall survival. Nintedanib works by blocking cells in the tumor's environment to delay tumor growth, and it is already approved for another lung condition called idiopathic pulmonary fibrosis. Participants will take Nintedanib tablets twice daily after meals, with a twelve-hour gap between doses. Alongside, they will take one EGFR-TKI tablet daily; options include gefitinib, erlotinib, afatinib, or osimertinib. Each treatment cycle lasts 30 days. Physical exams, blood tests, and CT scans will be conducted regularly, with blood samples collected every 6 weeks and tumor size measured by CT scans every 12 weeks. If participants experience serious side effects or liver problems, treatment may be delayed, dosages may be lowered, or treatment may stop entirely under the doctor's guidance. During the study, participants will have clinic visits at 6 and 12 weeks after starting treatment for exams and tests. After treatment ends, they will have follow-up visits including physical exams, blood tests, and CT scans to monitor tumor status. Researchers will assess treatment safety by monitoring side effects and changes in tumor size through chest CT scans every 6 weeks until disease progression. The study plans to enroll up to 20 participants and includes both Phase 1 and Phase 2 stages.

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