Combining Nintedanib with EGFR inhibitors for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• China Medical University Hospital
  Taichung, Taiwan Recruiting

Study contacts

• Study coordinator: Chih-Yen Tu
• Email: chesttu@gmail.com
• Phone: +886-975-681-007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.