Combining Nintedanib with EGFR inhibitors for advanced lung cancer
A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
This study is testing if combining a medication called Nintedanib with EGFR inhibitors can help people with advanced lung cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Drugs / interventions | gefitinib, erlotinib, afatinib, osimertinib |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06071013 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Nintedanib in combination with EGFR tyrosine kinase inhibitors (TKIs) for patients with advanced non-small cell lung cancer (NSCLC) that has become resistant to previous EGFR-TKI treatments. Participants will take Nintedanib twice daily and an EGFR TKI once daily over 30-day treatment cycles, with regular monitoring through physical exams, blood tests, and CT scans to assess tumor progression. The primary outcomes measured will be progression-free survival and overall survival, aiming to improve treatment options for this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 70 with advanced non-small cell lung cancer and confirmed EGFR mutations who have failed prior EGFR-TKI treatments.
Not a fit: Patients with serious side effects from previous EGFR-TKI treatments, known brain metastasis, or certain chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced EGFR-mutated NSCLC who have developed resistance to standard therapies.
How similar studies have performed: While combining targeted therapies is a common approach, the specific combination of Nintedanib with EGFR TKIs in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chih-Yen Tu
- Email: chesttu@gmail.com
- Phone: +886-975-681-007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.