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

ConditionsNon-small Cell Lung CancerEGFR Gene MutationEGFR-TKI Resistant Mutation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-70
SponsorChina Medical University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Nintedanib + gefitinib/erlotinib/afatinib/osimertinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The toxicity of combinate nintedanib and EGFR TKI

Time frame
Assessed every 6 weeks of chest CT scan until PD.
2

Patient objective response rate

Time frame
Assessed every 6 weeks of chest CT scan

Secondary outcomes

1

Overall survival

Time frame
Assessed every 12 weeks thereafter up to end of study at approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

China Medical University, Taiwan

Collaborator

Source ClinicalTrials.gov
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