In:
Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 99, No. 49 ( 2020-12-4), p. e23455-
Abstract:
Afatinib is an epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI) with proven efficacy for treating patients with advanced or metastatic non-small cell lung cancer (NSCLC). Unfortunately, responses are limited by acquired resistance. Because traditional Korean medicine may have synergistic effects when combined with chemotherapy or radiotherapy, the aim of our study is to elucidate the efficacy and safety of afatinib plus HangAmDan-B1 (HAD-B1) combination therapy in the treatment of patients with NSCLC, as well as EGFR mutations, who need afatinib therapy. Methods/design: This study is a randomized, multi-center, open clinical trial. A total of 142 eligible subjects, recruited at 8 centers, are randomly assigned to take Afatinib (20–40 mg) ± HAD-B1 (0.972 g/day) for 16 weeks. In the test group, HAD-B1 and afatinib will be used in combination. The primary outcome is a comparison of starting dose maintenance rate as well as the disease control rate (DCR) between afatinib monotherapy and afatinib plus HAD-B1 combination therapy in patients with local advanced or metastatic (Stage IIIA, B, C/IV) NSCLC. Secondary outcomes are the Progression Free Survival (PFS), Time to progression (TTP), Overall survival rate, ORR based on RESIST 1.1, tumor size reduction, health-related quality of life (HRQoL), and Tumor marker. Discussion: The result of this clinical trial will provide evidence for the efficacy and safety of using HAD-B1 in the treatment of EGFR-positive patients with locally advanced or metastatic NSCLC who require afatinib therapy. Trial registration: Clinical Research Information Service (CRIS), Republic of Korea (ID: KCT0005414), on September 23, 2020.
Type of Medium:
Online Resource
ISSN:
0025-7974
,
1536-5964
DOI:
10.1097/MD.0000000000023455
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2020
detail.hit.zdb_id:
2049818-4