A randomized, multi-center, open-label study to compare the safety and efficacy between afatinib monotherapy and combination therapy of afatinib and HAD-B1 for the locally advanced or metastatic NSCLC patients with EGFR mutations.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
04 12 2020
04 12 2020
Historique:
entrez:
8
12
2020
pubmed:
9
12
2020
medline:
22
12
2020
Statut:
ppublish
Résumé
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. This study is a randomized, multi-center, open clinical trial. A total of 178 eligible subjects, recruited at 8 centers, are randomly assigned to take Afatinib (20-40 mg) ± HAD-B1 (0.972 g/day) for 48 weeks. In the test group, HAD-B1 and afatinib will be used in combination. The primary outcome is a comparison of progression-free survival (PFS) 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 overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety. 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. Clinical Research Information Service (CRIS), Republic of Korea (ID: KCT0005414), on September 23, 2020.
Sections du résumé
BACKGROUND
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 178 eligible subjects, recruited at 8 centers, are randomly assigned to take Afatinib (20-40 mg) ± HAD-B1 (0.972 g/day) for 48 weeks. In the test group, HAD-B1 and afatinib will be used in combination. The primary outcome is a comparison of progression-free survival (PFS) 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 overall survival rates, clinical responses, tumor size reductions, health-related qualities of life, and safety.
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.
Identifiants
pubmed: 33285743
doi: 10.1097/MD.0000000000023455
pii: 00005792-202012040-00080
pmc: PMC7717758
doi:
Substances chimiques
Afatinib
41UD74L59M
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e23455Commentaires et corrections
Type : ErratumIn
Références
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Lancet Oncol. 2012 May;13(5):539-48
pubmed: 22452895
Lancet Oncol. 2016 May;17(5):577-89
pubmed: 27083334
Lung Cancer. 2013 Nov;82(2):179-89
pubmed: 24011633
J Clin Oncol. 2013 Sep 20;31(27):3327-34
pubmed: 23816960
J Clin Oncol. 2008 May 20;26(15):2442-9
pubmed: 18458038
Integr Cancer Ther. 2019 Jan-Dec;18:1534735419830765
pubmed: 30866688
Integr Cancer Ther. 2019 Jan-Dec;18:1534735419827079
pubmed: 30836771
Lancet Oncol. 2015 Aug;16(8):897-907
pubmed: 26156651
Ann Oncol. 2016 Mar;27(3):417-23
pubmed: 26646759
Mol Med Rep. 2018 May;17(5):6745-6751
pubmed: 29512755
Int J Cancer. 2017 Jun 15;140(12):2805-2819
pubmed: 28295308
J Clin Oncol. 2013 Sep 20;31(27):3335-41
pubmed: 23816963
BMJ Open. 2020 Apr 9;10(4):e034499
pubmed: 32276954
BMC Cancer. 2019 Sep 9;19(1):896
pubmed: 31500587
Complement Ther Med. 2014 Dec;22(6):1010-8
pubmed: 25453521
Front Pharmacol. 2019 Jul 02;10:732
pubmed: 31333456
Lancet Oncol. 2012 May;13(5):528-38
pubmed: 22452896
J Oncol Pharm Pract. 2020 Sep;26(6):1461-1474
pubmed: 32567494
Lancet Oncol. 2014 Feb;15(2):213-22
pubmed: 24439929
Am J Cancer Res. 2015 Aug 15;5(9):2892-911
pubmed: 26609494
Transl Lung Cancer Res. 2015 Feb;4(1):36-54
pubmed: 25806345
Medicine (Baltimore). 2020 Jan;99(4):e18735
pubmed: 31977865