Open AccessAfatinib + bevacizumab combination therapy in EGFR ‐mutant NSCLC patients with osimertinib resistance: Protocol of an open‐label , phase II , multicenter, single‐arm trial
Author(s) -
Kobayashi Nobuaki,
Hashimoto Hisashi,
Kamimaki Chisato,
Nagasawa Ryo,
Tanaka Katsushi,
Kubo Sousuke,
Katakura Seigo,
Chen Hao,
Hirama Nobuyuki,
Ushio Ryota,
Aoki Ayako,
Nakashima Kentaro,
Teranishi Shuhei,
Manabe Saki,
Watanabe Hiroki,
Horita Nobuyuki,
Watanabe Keisuke,
Hara Yu,
Yamamoto Masaki,
Kudo Makoto,
Piao Hongmei,
Kaneko Takeshi
Publication year - 2020
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.13503
Subject(s) - afatinib , medicine , osimertinib , bevacizumab , lung cancer , clinical endpoint , phases of clinical research , epidermal growth factor receptor , oncology , pharmacology , clinical trial , cancer , erlotinib , chemotherapy
As most patients with epidermal growth factor receptor ( EGFR )‐mutant non‐small cell lung cancer (NSCLC) develop progressive disease after treatment with osimertinib, it is important to develop more effective treatment options. Afatinib has been shown to be more effective in in vitro studies than osimertinib when used in cancer cell lines containing some specific EGFR mutations. Therefore, afatinib may be an effective solution, especially when used in combination with an anti‐VEGF agent such as bevacizumab. Methods A phase II multicenter, open‐label, single‐arm trial has been initiated to evaluate the efficacy and safety of afatinib and bevacizumab combination as salvage therapy for EGFR ‐mutated lung cancer in patients previously treated with osimertinib. The primary endpoint will be the objective response rate (ORR) and secondary endpoints are progression‐free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events (AEs). Discussion A previous study indicated that afatinib inhibits lung cancer cells with specific EGFR mutations more effectively than other EGFR‐TKIs such as osimertinib. Therefore, we expect that combination therapy using afatinib and bevacizumab will be effective in patients previously treated with osimertinib (registration no. jRCTs031190077).