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Recruiting NCT06071013

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

Phase I / Phase II Interventional Non-small Cell Lung Cancer EGFR Gene Mutation EGFR-TKI Resistant Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients

Overview

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

Detailed description

The efficacy of the regimen is evaluated by participants' progression-free survival and overall survival.

Nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. Nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic.

The participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. EGFR TKI-gefitinib, erlotinib, afatinib, or osimertinib will be taken 1 tablet once per day during each treatment cycle. The treatment cycle in this study is 30 days.

In this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. In the 6 weeks of the study, the participants will have blood tests and a CT scan. About 5cc of blood will be collected each time. In addition, the participant's tumor will be measured by a CT scan every 12 weeks.

If the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. It may even be necessary to stop your treatment. The doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic.

After treatment ends, the participants will have a follow-up visit at the clinic. At this visit, the participants will have a complete physical exam, including blood (about 5cc) tests and CT scan to measure the size of the tumors.

This is an investigational study. Up to 20 participants will take part in this study.

Interventions

  • Drug Nintedanib, gefitinib, erlotinib, afatinib, osimertinib
    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 prol

Primary outcome measures

  • The toxicity of combinate nintedanib and EGFR TKI [Time frame: Assessed every 6 weeks of chest CT scan until PD.]
  • Patient objective response rate [Time frame: Assessed every 6 weeks of chest CT scan]
Secondary outcome measures (1)
  • Overall survival [Time frame: Assessed every 12 weeks thereafter up to end of study at approximately 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT06071013 · CMUH112-REC2-121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗