Multi-center, randomized, double-blind, placebo-controlled, exploratory study to evaluate the efficacy and safety of HAD-B1 for dose-finding in EGFR positive and locally advanced or metastatic NSCLC subjects who need Afatinib therapy: Study protocol clinical trial (SPIRIT Compliant)
| Autor: | Hyung-Joon Jun, So-Jung Park, Hwa-Seung Yoo, Seong-Hoon Shin, Hwi-joong Kang |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Lung Neoplasms Afatinib afatinib Panax Placebo 03 medical and health sciences 0302 clinical medicine Gefitinib Double-Blind Method Study Protocol Clinical Trial Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Medicine Humans Multicenter Studies as Topic 030212 general & internal medicine Progression-free survival Epidermal growth factor receptor Boswellia Protein Kinase Inhibitors non-small cell lung cancer Randomized Controlled Trials as Topic biology business.industry Plant Extracts General Medicine Medicine Korean Traditional Clinical trial ErbB Receptors Drug Combinations Treatment Outcome 030220 oncology & carcinogenesis Cordyceps herbal medicine randomized controlled trial biology.protein Female Erlotinib business HAD-B1 medicine.drug Research Article |
| Zdroj: | Medicine |
| ISSN: | 1536-5964 |
| Popis: | Background: In recent studies, afatinib, a second-generation inhibitor, showed superior outcomes, when compared to the first-generation of EGFR-tyrosine kinase inhibitors (TKIs), such as erlotinib and gefitinib, in patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of epidermal growth factor receptor (EGFR). Patients who receive TKIs with a significant initial efficacy, inevitably experience an acquired resistance (AR) within 9 to 13 months. Traditional Korean medicine may have synergistic effects when combined with chemotherapy or radiotherapy. The purpose of this trial is to assess whether afatinib plus HAD-B1 improves disease control rates (DCRs) compared with afatinib alone and to evaluate the efficacy and safety of HAD-B1 for finding the proper dose. Methods: This is a randomized, double-blind, placebo-controlled, multi-center, therapeutic, exploratory clinical trial. This trial is designed to determine whether HAD-B1 combined with afatinib results in better DCRs with less toxicity than afatinib alone. A total of 66 NSCLC patients with EGFR mutations will be randomly assigned to treatment group 1 (afatinib 40 mg/day plus HAD-B1 972 mg), treatment group 2 (afatinib 40 mg/day plus HAD-B1 1944 mg) and a control group (afatinib 40 mg/day). Afatinib combined with HAD-B1 or with a placebo will be administered to the participants for 12 weeks. The primary endpoint is a comparison of the DCRs among groups. Secondary endpoints are comparisons of the complete response (CR) and the partial response (PR) to the treatment, the stability of the disease (SD), progression free survival (PFS), time to progression (TTP), and tumor marker (CEA, NSE) and WBC differential count (LMR, NLR) and natural killer cell activity and quality of life (QOL) among groups. Discussion: The results from this clinical trial will provide evidence of efficacy and safety of HAD-B1 in EGFR positive and locally advanced or metastatic NSCLC patients who need afatinib therapy. |
| Databáze: | OpenAIRE |
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