TY - JOUR
T1 - A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non–Small-cell Lung Cancer
T2 - The OPAL Study (NEJ032C/LOGIK1801)
AU - Asahina, Hajime
AU - Tanaka, Kentaro
AU - Morita, Satoshi
AU - Maemondo, Makoto
AU - Seike, Masahiro
AU - Okamoto, Isamu
AU - Oizumi, Satoshi
AU - Kagamu, Hiroshi
AU - Takahashi, Kazuhisa
AU - Kikuchi, Toshiaki
AU - Isobe, Takeshi
AU - Sugio, Kenji
AU - Kobayashi, Kunihiko
N1 - Funding Information:
K.H. assumed an advisory role for ImmuniT Research Inc. K.T. received honoraria from Abbott Japan. H.A., Ke.T., M.M., I.O., S.O., H.K., K.T., T.I., and K.K. received honoraria from AstraZeneca. Ke.T. received honoraria from Abbvie. H.A., K.T., T.I., and K.K. received honoraria from Boehringer Ingelheim. H.K., K.T., and K.K. received honoraria from Bristol-Myers Squibb. H.A., Ke.T., H.K., K.T., and K.K. received honoraria from Chugai. K.T. received honoraria from Daiichi-Sankyo. K.T. received honoraria from Eisai. H.A., Ke.T., M.M., I.O., S.O., K.T., and K.K. received honoraria from Eli Lilly. K.T. received honoraria from Kyorin. H.A. and Ke.T. received honoraria from Kyowa Hakko Kirin. H.A., Ke.T., and K.T. received honoraria from MSD. K.T. received honoraria from Mylan. K.T. received honoraria from Meiji Seika Pharma. Ke.T. received honoraria from Novartis. Ke.T. received honoraria from NBI. Ke.T., H.K., K.T., and K.K. received honoraria from Ono Pharmaceutical. Ke.T., K.T., and T.I. received honoraria from Pfizer. Ke.T. received honoraria from SRL. K.T., H.K., and K.K. received honoraria from Taiho. K.T. provided a paid expert testimony for AstraZeneca. I.O., S.O., K.T., and T.I. received research funding from AstraZeneca . K.T. received research funding from Bayer . H.K. and K.T. received research funding from Boehringer Ingelheim . Ke.T., H.K., and K.T. received research funding from Chugai . K.T. and T.I. received research funding from Daiichi-Sankyo . I.O., H.K., and K.T. received research funding from Eli Lilly . K.T. received research funding from Kyorin. K.T. received research funding from MSD . K.T. received research funding from Novartis . K.T. received research funding from NBI . Ke.T., H.K., and K.T. received research funding from Ono Pharmaceutical . K.T. received research funding from Pfizer . K.T. received research funding from Sanofi . H.K. and K.T. received research funding from Taiho. K.T. received research funding from Takeda . K.T. received research funding from Tsumura . The remaining authors declare that they have no competing interests.
Funding Information:
The present study is funded by AstraZeneca (England). The authors would like to thank the late professor Yoshiki Ishii, MD, PhD, of Dokkyo Medical University for helping promote this collaborative clinical study. The authors are also grateful to the data managers and other support staff of the North East Japan Study Group and Lung Oncology Group in Kyushu. This study will be conducted with support from the North East Japan Study Group Data Center, Saitama, Japan.
PY - 2020
Y1 - 2020
N2 - Background: Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is now a standard treatment of previously untreated EGFR-mutated advanced non–small-cell lung cancer (NSCLC). However, disease progression occurs within 19 months of treatment. In the NEJ009 study, gefitinib plus carboplatin plus pemetrexed demonstrated significantly better progression-free and overall survival compared with gefitinib monotherapy. Furthermore, the Lung Oncology Group in Kyushu and North East Japan Study Group, major clinical trial groups in Japan, conducted a randomized phase II study to evaluate the efficacy and safety of second-line osimertinib plus carboplatin plus pemetrexed versus osimertinib monotherapy for patients with disease progression during first-line EGFR tyrosine kinase inhibitor therapy and the EGFR T790M resistance mutation (TAKUMI trial; trial registration no., jRCTs071180062). In the first treatment course for the initial 24 patients, no safety issues were reported in the combination arm. Thus, we have planned this phase II study to evaluate the safety and preliminary efficacy of osimertinib plus cisplatin/carboplatin plus pemetrexed therapy for patients with previously untreated EGFR-mutated NSCLC. Patients and Methods: A total of 66 patients will be enrolled, because this sample size will be adequate for assessing treatment safety and efficacy. The co-primary endpoints include safety and the objective response rate, and the secondary endpoints include the complete response rate, disease control rate, and progression-free survival. Conclusions: This is the first study to explore the efficacy and safety of osimertinib combined with platinum-based chemotherapy in previously untreated NSCLC patients with EGFR-sensitizing mutations. Our findings could provide valuable information for phase III studies such as FLAURA2 and for developing treatment strategies for EGFR-mutated NSCLC.
AB - Background: Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is now a standard treatment of previously untreated EGFR-mutated advanced non–small-cell lung cancer (NSCLC). However, disease progression occurs within 19 months of treatment. In the NEJ009 study, gefitinib plus carboplatin plus pemetrexed demonstrated significantly better progression-free and overall survival compared with gefitinib monotherapy. Furthermore, the Lung Oncology Group in Kyushu and North East Japan Study Group, major clinical trial groups in Japan, conducted a randomized phase II study to evaluate the efficacy and safety of second-line osimertinib plus carboplatin plus pemetrexed versus osimertinib monotherapy for patients with disease progression during first-line EGFR tyrosine kinase inhibitor therapy and the EGFR T790M resistance mutation (TAKUMI trial; trial registration no., jRCTs071180062). In the first treatment course for the initial 24 patients, no safety issues were reported in the combination arm. Thus, we have planned this phase II study to evaluate the safety and preliminary efficacy of osimertinib plus cisplatin/carboplatin plus pemetrexed therapy for patients with previously untreated EGFR-mutated NSCLC. Patients and Methods: A total of 66 patients will be enrolled, because this sample size will be adequate for assessing treatment safety and efficacy. The co-primary endpoints include safety and the objective response rate, and the secondary endpoints include the complete response rate, disease control rate, and progression-free survival. Conclusions: This is the first study to explore the efficacy and safety of osimertinib combined with platinum-based chemotherapy in previously untreated NSCLC patients with EGFR-sensitizing mutations. Our findings could provide valuable information for phase III studies such as FLAURA2 and for developing treatment strategies for EGFR-mutated NSCLC.
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U2 - 10.1016/j.cllc.2020.09.023
DO - 10.1016/j.cllc.2020.09.023
M3 - Article
C2 - 33199228
AN - SCOPUS:85096370912
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
ER -