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

Sponsor
China Medical University Hospital
Study ID
NCT06071013
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nintedanib, gefitinib, erlotinib, afatinib, osimertinib — DRUG
    Nintedanib is a multiple tyrosine kinase inhibitor that can bind competitively to the ATP-binding pocket of these receptors and block intracellular signaling, which is critical for the proliferation and migration. Gefitinib, erlotinib and afatinib are the first- and second- generation of EGFR tyrosine kinase inhibitors that reversibly and irreversibly inhibit the binding of ATP to the phosphate-binding loop of ATP binding site in the kinase domain of EGFR, leading to the inhibition of cell proliferation and induction of apoptosis of cancer cells.

Study Details

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 Dates

Start date
Feb 23, 2024
Status verified
Jan 2025
Primary completion
Aug 27, 2026
Completion
Aug 27, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nintedanib + gefitinib/erlotinib/afatinib/osimertinib
    Nintedanib will administered orally twice per day Gefitinib will administered orally once daily Erlotinib will administered orally once daily Afatinib will administered orally once daily Osimertinib will administered orally once daily

Primary Outcome Measure

The toxicity of combinate nintedanib and EGFR TKI [ Time Frame: Assessed every 6 weeks of chest CT scan until PD. ]

Central Contacts

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