Cb + weekly PTX showed survival benefits compared with vinorelbine or gemcitabine in elderly patients with NSCLC.1 However, D alone is still one of the standard therapies for them.2 The 130-nm albumin-bound formulation of PTX (nab-PTX,) has shown activity in NSCLC. Cb + nab-PTX demonstrated a significantly higher overall response rate (ORR) than Cb + PTX in patients with Sq histology (41% vs 24%, p 70 years showed a significantly increased overall survival (OS) with Cb + nab-PTX versus Cb + PTX.3
This is a randomized, multicenter, phase 3 trial to compare the efficacy and safety of Cb + nab-PTX with D for elderly patients for advanced Sq NSCLC. Elderly patients (> 70 years) who have received no prior chemotherapy for advanced/metastatic Sq NSCLC are randomized 1:1 to D (60 mg/m2 i.v.) on day1 and Cb (AUC 6) on day 1 plus nab-PTX (100 mg/m2 i.v.) on day1, 8, and 15 of each 21-day cycle. Randomization is balanced by minimization for ECOG performance status, stage, age, gender and institutes. Treatment continues until radiographic progression or unacceptable toxicity. The primary endpoint is improvement of OS with Cb + nab-PTX versus D. Secondary endopoints are to assess ORR, progression-free survival, safety and quality of life. Recruitment began in December 2015 and planned enrollment is 250 patients. 1 Quiox E et al. Lancet 2011 2 Kudoh S et al. J Clin Oncol 2006 3 Socinski MA et al. J Clin Oncol 2012
Clinical trial identification
Legal entity responsible for the study
This study was conducted by National Hospital Organization Nagoya Medical Center, under the funding contract with Taiho Pharmaceutical Co. Ltd., Japan.
H. Saka: Research funding for AstraZeneca, Daiichi Sankyo, Ono, Lilly, Bristol Myers, Beyer, NPO-WJOG, Taiho, MSD, Linical. Y. Takiguchi: Honoraria for Taiho, Ono, Eli Lilly, Astra Zeneca, Nippon Kayaku, Kyowa-Hakko Kirin. Research Funding for Taiho Pharmaceutical, Ono Pharmaceutical, Eli Lilly, Boehringer Ingelheim, Pfizer, Chugai, Kyowa-Hakko Kirin. S. Atagi: Honoraria for Chugai, Boehringer Ingelheim, AstraZeneca, Taiho, Eli Lilly. Research Funding for Chugai, Pfizer, Ono, Merck Serono, Boehringer Ingelheim, AstraZeneca, Taiho, Yakult, Eli Lilly. T. Kurata: Honoraria for AstraZeneca, Eli Lilly, Chugai, Pfizer, Boehringer Ingelheim. A. Inoue: Honoraria for Taiho Pharmaceutical. K. Kubota: Honoraria for Chugai, Taiho, Daiichi-Sankyo. M. Takenoyama: Honoraria for AstraZeneca, Chugai, Eli Lilly Japan, Kyowa Hakko Kirin, Ono, Taiho. Research funding for Bristol-Myers, Chugai, Eli Lilly Japan, Nippon Boehringer Ingelheim, Novartis, Ono. T. Seto: Honoraria or Research funds for Astellas, AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa Hakko Kirin, Merck Serono, MSD, Nippon Boehringer Ingelheim, Nippon Kayaku, Novartis Pharma, Ono, Pfizer, Sanofi, Taiho, Verastem, Yakult T. Yamanaka: Honoraria for Takeda, Chugai, Taiho. N. Yamamoto: Honoraria for Chugai, AstraZeneca, MSD, Pfizer, Boehringer Ingelheim, Taiho, Eli Lilly, Ono. Consulting or advisory role for Chugai, AstraZeneca, Pfizer, Boehringer Ingelheim, Taiho, Eli Lilly, Ono. Research Funding for Chugai, Boehringer Ingelheim. A. Gemma: Speaker's Bureau for Taiho. Y. Ichinose: Honoraria for Chugai Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Taiho Pharmaceutical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd. Research funding for Takeda Bio Development Center Ltd., Nippon Kayaku Co., Ltd. All other authors have declared no conflicts of interest.