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

• Status: Not yet recruiting
• Trial end date: 2026-08-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Treatments: Afatinib; Erlotinib Hydrochloride; Gefitinib; Nintedanib

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, and afatinib.

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 EGFR T790M mutation.

6. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).