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

NCT06071013 | Recruiting Phase 1 DMC

• 1 other identifier: CMUH112-REC2-121
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-small Cell Lung Cancer; EGFR Gene Mutation; EGFR-TKI Resistant Mutation

Keywords

nPKC delta; Angiogenesis; EGFR TKI drug resistant

Outcome Measures

Primary Outcomes (2)

• The toxicity of combinate nintedanib and EGFR TKI

  Assessed every 6 weeks of chest CT scan until PD.

• Patient objective response rate

  Assessed every 6 weeks of chest CT scan

Secondary Outcomes (1)

• Overall survival

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

Study Arms (1)

Nintedanib + gefitinib/erlotinib/afatinib/osimertinib

EXPERIMENTAL

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

Drug: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib

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.

Nintedanib + gefitinib/erlotinib/afatinib/osimertinib

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• China Medical University Hospital: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nintedanib; Gefitinib; Erlotinib Hydrochloride; Afatinib; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amides; Organic Chemicals

Study Officials

• Pulmonary Medicine

  China Medical University Hospital

  STUDY DIRECTOR

Central Study Contacts

Chih-Yen Tu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 6, 2023
• Study Start: February 23, 2024
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

TW (1)