Forthcoming Phase II Study of Durvalumab (MEDI4736) Plus Chemotherapy for Small Cell Lung Cancer with Brain Metastases.

"Disclosure Dr. Shiraishi 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. Dr. Tsuchiya-Kawano has received honoraria from AstraZeneca, Bristol-Myers Squibb, Taiho Pharmaceutical, Chugai Pharma, Ono Pharmaceutical, and Kyowa Kirin, all outside the submitted work. Dr. Ishii has received honoraria from AstraZeneca, Chugai Pharma, Ono Pharmaceutical, Bristol-Myers Squibb, MSD Oncology, and AMCO, all outside the submitted work. Dr. Daga has received honoraria from AstraZeneca, Chugai Pharma, and Eli Lilly, all outside the submitted work. Dr. Ito has received honoraria from TAKEDA, Boehringer-Ingelheim, Eli Lilly, Chugai Pharma, AstraZeneca, Pfizer, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, and Daiichi-Sankyo, all outside the submitted work. Dr. Okamoto 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 in this work."

"We thank the patients, their families, and all of the investigators who participate in the study (Supplementary Table). This study is a collaboration of the Lung Oncology Group in Kyushu (LOGiK). Data management and monitoring for the study are conducted by Clinical Research Support Center Kyushu under a funding contract with AstraZeneca. Disclosure: Dr. Shiraishi 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. Dr. Tsuchiya-Kawano has received honoraria from AstraZeneca, Bristol-Myers Squibb, Taiho Pharmaceutical, Chugai Pharma, Ono Pharmaceutical, and Kyowa Kirin, all outside the submitted work. Dr. Ishii has received honoraria from AstraZeneca, Chugai Pharma, Ono Pharmaceutical, Bristol-Myers Squibb, MSD Oncology, and AMCO, all outside the submitted work. Dr. Daga has received honoraria from AstraZeneca, Chugai Pharma, and Eli Lilly, all outside the submitted work. Dr. Ito has received honoraria from TAKEDA, Boehringer-Ingelheim, Eli Lilly, Chugai Pharma, AstraZeneca, Pfizer, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, and Daiichi-Sankyo, all outside the submitted work. Dr. Okamoto 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 in this work."

"This study is being conducted in accordance with the precepts established in the Declaration of Helsinki and Clinical Trials Act of Japan. The study protocol was approved by the central certified review board (CRB) of Clinical Research Network Fukuoka (certification number: CRB7180004) in April 2021, before initiation of patient enrollment. The CRB of Clinical Research Network Fukuoka was established independently of the participating institutions and reviews clinical trials from various centers. This trial has been registered in the Japan Registry for Clinical Trials as jRCTs071210036. All participants in this trial have provided written informed consent."