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NCT Number: NCT06071013

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Gene Mutation EGFR-TKI Resistant Mutation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

China Medical University Hospital

Taichung, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Yen Tu

CONTACT

[email protected]

+886-975-681-007

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • China Medical University, Taiwan

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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