TY - JOUR
T1 - A Multicenter, Randomized Phase III Study Comparing Platinum Combination Chemotherapy Plus Pembrolizumab With Platinum Combination Chemotherapy Plus Nivolumab and Ipilimumab for Treatment-Naive Advanced Non–Small Cell Lung Cancer Without Driver Gene Alterations
T2 - JCOG2007 (NIPPON Study)
AU - Shiraishi, Yoshimasa
AU - Hakozaki, Taiki
AU - Nomura, Shogo
AU - Kataoka, Tomoko
AU - Tanaka, Kentaro
AU - Miura, Satoru
AU - Sekino, Yuta
AU - Ando, Masahiko
AU - Horinouchi, Hidehito
AU - Ohe, Yuichiro
AU - Okamoto, Isamu
N1 - Funding Information:
We thank the patients, their families, and all of the investigators participating in the study. This study is conducted by JCOG with support in part from the National Cancer Center Research and Development Fund (2020-J-3) and from the Japan Agency for Medical Research and Development (AMED, grant no. JP21ck0106669h0001 ).
Funding Information:
We thank the patients, their families, and all of the investigators participating in the study. This study is conducted by JCOG with support in part from the National Cancer Center Research and Development Fund (2020-J-3) and from the Japan Agency for Medical Research and Development (AMED, grant no. JP21ck0106669h0001). Y. S. has received research grants from Chugai Pharma as well as honoraria from Chugai Pharma, Eli Lilly, Ono Pharmaceutical, AstraZeneca, and Taiho Pharmaceutical, all outside the submitted work. S.N. has received research grants from Amgen and AstraZeneca as well as honoraria from AstraZeneca, Chugai Pharma, Pfizer, and Taiho Pharmaceutical, all outside the submitted work. K.T. has received honoraria from Chugai Pharma and AstraZeneca, all outside the submitted work. S.M. has received honoraria from Chugai Pharma, Eli Lilly, Boehringer-Ingelheim, AstraZeneca, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, and BMS, all outside the submitted work. M.A. has received research grants from Kyowa Kirin Co. Ltd. outside the submitted work. H.H. has received research grants from MSD, Abbvie, AstraZeneca, BMS, Ono, Merck Biophama, Daiichi-Sankyo, Janssen, Genomic Helath, Chugai, Roche, and Novartis as well as honoraria from AstraZeneca, MSD, Eli Lilly, Ono, BMS, Chugai, Roche, Kyowa-Kirin, and Novartis, all outside the submitted work. Y.O. has acted as an advisor to AstraZeneca, Chugai, ONO, BMS, Kyorin, Celltrion, Amgen, and Nippon Kayaku; and has received honoraria from AstraZeneca, Chugai, Eli Lilly, ONO, BMS, Boehringer Ingelheim, Bayer, Pfizer, MSD, Taiho, Nippon Kayaku, and Kyowa Hakko Kirin; and has received research expenses from AstraZeneca, Chugai, Lilly, ONO, BMS, Kyorin, Dainippon- Sumitomo, Pfizer, Taiho, Novartis, Ignyta, Takeda, Kissei, Daiichi-Sankyo, Janssen, and LOXO. I.O. has received research grants and personal fees from AstraZeneca, Taiho Pharmaceutical, Chugai Pharma, Boehringer-Ingelheim, Ono Pharmaceutical, MSD Oncology, Eli Lilly, and Bristol-Myers Squibb; research grants from Astellas Pharma, Novartis, and AbbVie; and personal fees from Pfizer, all outside the submitted work. The remaining authors have declared no competing interests.
Funding Information:
Y. S. has received research grants from Chugai Pharma as well as honoraria from Chugai Pharma, Eli Lilly, Ono Pharmaceutical, AstraZeneca, and Taiho Pharmaceutical, all outside the submitted work. S.N. has received research grants from Amgen and AstraZeneca as well as honoraria from AstraZeneca, Chugai Pharma, Pfizer, and Taiho Pharmaceutical, all outside the submitted work. K.T. has received honoraria from Chugai Pharma and AstraZeneca, all outside the submitted work. S.M. has received honoraria from Chugai Pharma, Eli Lilly, Boehringer-Ingelheim, AstraZeneca, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, and BMS, all outside the submitted work. M.A. has received research grants from Kyowa Kirin Co. Ltd., outside the submitted work. H.H. has received research grants from MSD, Abbvie, AstraZeneca, BMS, Ono, Merck Biophama, Daiichi-Sankyo, Janssen, Genomic Helath, Chugai, Roche, and Novartis as well as honoraria from AstraZeneca, MSD, Eli Lilly, Ono, BMS, Chugai, Roche, Kyowa-Kirin, and Novartis, all outside the submitted work. Y.O. has acted as an advisor to AstraZeneca, Chugai, ONO, BMS, Kyorin, Celltrion, Amgen, and Nippon Kayaku; and has received honoraria from AstraZeneca, Chugai, Eli Lilly, ONO, BMS, Boehringer Ingelheim, Bayer, Pfizer, MSD, Taiho, Nippon Kayaku, and Kyowa Hakko Kirin; and has received research expenses from AstraZeneca, Chugai, Lilly, ONO, BMS, Kyorin, Dainippon- Sumitomo, Pfizer, Taiho, Novartis, Ignyta, Takeda, Kissei, Daiichi-Sankyo, Janssen, and LOXO. I.O. has received research grants and personal fees from AstraZeneca, Taiho Pharmaceutical, Chugai Pharma, Boehringer-Ingelheim, Ono Pharmaceutical, MSD Oncology, Eli Lilly, and Bristol-Myers Squibb; research grants from Astellas Pharma, Novartis, and AbbVie; and personal fees from Pfizer, all outside the submitted work. The remaining authors have declared no competing interests.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2022/6
Y1 - 2022/6
N2 - Background: First-line treatment of non–small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination chemotherapy together with an immune checkpoint inhibitor, regardless of the expression level of the programmed cell death–1 (PD-1) ligand PD-L1 on tumor cells. Moreover, such chemotherapy plus nivolumab (antibody to PD-1) and ipilimumab (antibody to cytotoxic T lymphocyte–associated protein–4) prolonged survival in advanced NSCLC patients compared with chemotherapy alone. We have now designed a randomized, controlled phase III trial (NIPPON, JCOG2007) to confirm that platinum combination chemotherapy plus nivolumab and ipilimumab is superior to such chemotherapy plus pembrolizumab (antibody to PD-1) for treatment-naive patients with advanced NSCLC. Patients and Methods: 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 platinum combination chemotherapy and either pembrolizumab or nivolumab plus ipilimumab. Patients with known genetic driver alterations such as those affecting EGFR or ALK are excluded. Enrollment of 422 patients over 3 years at 55 oncology facilities throughout Japan is planned. The primary endpoint is overall survival. In addition, as ancillary research, metagenomic analysis of the gut microbiota will be performed with fecal samples collected before treatment onset, and the results will be examined for their association to therapeutic effect and adverse events. Conclusion: If the primary endpoint is met, platinum combination chemotherapy together with nivolumab plus ipilimumab will be established as a new, more effective standard treatment for advanced NSCLC.
AB - Background: First-line treatment of non–small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination chemotherapy together with an immune checkpoint inhibitor, regardless of the expression level of the programmed cell death–1 (PD-1) ligand PD-L1 on tumor cells. Moreover, such chemotherapy plus nivolumab (antibody to PD-1) and ipilimumab (antibody to cytotoxic T lymphocyte–associated protein–4) prolonged survival in advanced NSCLC patients compared with chemotherapy alone. We have now designed a randomized, controlled phase III trial (NIPPON, JCOG2007) to confirm that platinum combination chemotherapy plus nivolumab and ipilimumab is superior to such chemotherapy plus pembrolizumab (antibody to PD-1) for treatment-naive patients with advanced NSCLC. Patients and Methods: 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 platinum combination chemotherapy and either pembrolizumab or nivolumab plus ipilimumab. Patients with known genetic driver alterations such as those affecting EGFR or ALK are excluded. Enrollment of 422 patients over 3 years at 55 oncology facilities throughout Japan is planned. The primary endpoint is overall survival. In addition, as ancillary research, metagenomic analysis of the gut microbiota will be performed with fecal samples collected before treatment onset, and the results will be examined for their association to therapeutic effect and adverse events. Conclusion: If the primary endpoint is met, platinum combination chemotherapy together with nivolumab plus ipilimumab will be established as a new, more effective standard treatment for advanced NSCLC.
UR - http://www.scopus.com/inward/record.url?scp=85119422075&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85119422075&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2021.10.012
DO - 10.1016/j.cllc.2021.10.012
M3 - Article
C2 - 34802879
AN - SCOPUS:85119422075
VL - 23
SP - e285-e288
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 4
ER -
