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

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation

In brief

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

Key facts

Study ID

NCT06071013

Run by

China Medical University Hospital

People needed

20

Starts

2024-02-23

Expected to finish

2026-08-27

Last updated by the study team

2025-01-23

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
• Positive EGFR mutations are diagenesis.
• 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.
• Participants must have adequate hepatic, renal, and bone marrow function

You may not qualify if…

• Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
• Participants have known hypertension, and chronic liver and gastrointestinal disease.
• Participants have known brain metastasis.
• Female participants who are pregnant or breast-feeding
• Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).

Where it is running

• China Medical University Hospital — Taichung, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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