RecruitingPhase 1/2

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

Taiwan20 participantsStarted 2024-02-23

Plain-language 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

Who can participate

Age range20 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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).

What they're measuring

The toxicity of combinate nintedanib and EGFR TKI

Timeframe: Assessed every 6 weeks of chest CT scan until PD.

Patient objective response rate

Timeframe: Assessed every 6 weeks of chest CT scan

Trial details

NCT IDNCT06071013

SponsorChina Medical University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-27

Contact for this trial

Chih-Yen Tu

+886-975-681-007 chesttu@gmail.com

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials