2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
A multicenter, open label, randomized phase III study of atezolizumab with platinum-pemetrexed and with or without bevacizumab for patients with advanced nonsquamous non-small cell lung cancer (WJOG11218L APPLE Study).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #442b)
J Clin Oncol 37, 2019 (suppl; abstr TPS9125)
Author(s): Yoshimasa Shiraishi, Haruko Daga, Satoshi Ikeda, Akito Hata, Hideaki Mizutani, Tomohiro Sakamoto, Haruhiro Saito, Osamu Hataji, Hiroshi Tanaka, Atsushi Horiike, Hideo Saka, Tsuneo Shimokawa, Masahide Mori, Katsuya Hirano, Koichi Azuma, Tetsuya Mitsudomi, Takashi Seto, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Isamu Okamoto; Kyushu University Hospital, Fukuoka, Japan; Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan; Kurashiki Central Hospital, Kurashiki City, Japan; Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan; Saitama Cancer Center, Saitama, Japan; Tottori University Hospital, Yonago, Japan; Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan; Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan; Department of Respiratory Medicine, Niigata Cancer Center Hospital, Niigata, Japan; Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Department of Respiratory Medicine, Nagoya Medical Center, Nagoya, Japan; Yokohama Municipal Citizen's Hospital, Yokohama-Shi, Japan; Department of Internal Medicine, Toneyama National Hospital, Toyonaka, Japan; Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan; Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan; Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Japan; National Kyushu Cancer Center, Fukuoka, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan; Kindai University Hospital, Osaka, Japan
Background: First-line treatment of non–small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with an immune-checkpoint inhibitor. Bevacizumab is expected to enhance not only chemotherapy but also the efficacy of immune-checkpoint inhibitors through blockade of vascular endothelial growth factor–mediated immunosuppression. The aim of this trial is to demonstrate an additional effect of bevacizumab administered together with platinum combination therapy and the immune-checkpoint inhibitor atezolizumab in patients with advanced nonsquamous NSCLC. Methods: Cytotoxic chemotherapy–naïve patients aged 20 years or older with a performance status of 0 or 1 are randomly assigned in a 1:1 ratio to receive either atezolizumab plus pemetrexed-carboplatin (APP) or atezolizumab, pemetrexed-carboplatin, and bevacizumab (APPB). Patients with genetic driver alterations such as those affecting EGFR or ALK are included if they have experienced disease progression or unacceptable side effects during treatment with at least one approved tyrosine kinase inhibitor. After four cycles of induction therapy, maintenance therapy with atezolizumab plus pemetrexed or with atezolizumab plus pemetrexed plus bevacizumab is administered for up to 2 years until evidence of disease progression or development of unacceptable toxicity. The primary end point is progression-free survival (according to central image review). Secondary end points are progression-free survival (determined by the attending physician), overall survival, response rate, response duration, and adverse events. Stratification factors are PD-L1 tumor proportion score (≥50% vs. < 50%), stage, and driver gene alterations. We determined that, with a sample size of 350 patients (175 in each arm), the trial will have 80% power to show a hazard ratio for disease progression or death of 0.727 at a one-sided alpha level of 0.025 (as calculated on the basis of 311 such events) for comparison between the APPB and APP groups. Clinical trial information: 194565.