296
Participants
Start Date
August 16, 2021
Primary Completion Date
February 23, 2026
Study Completion Date
December 23, 2026
Penpulimab
Arm A: Penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) +cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/ m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), 3 weeks (21 days) per cycle; followed by penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment.
placebo
Arm B: Placebo (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), every 3 weeks (21 days) per cycle; followed by placebo(200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment. Subjects in Arm B will have the opportunity to crossover to openlabel treatment with penpulimab monotherapy after radiographic disease progression.
St Vincent's Public Hospital Sydney, Darlinghurst
Genesis Care North Shore, St Leonards
Sir Charles Gardner, Heidelberg
Austin Health, Nedlands
Icahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
Winship Cancer Institute/Emory University, Atlanta
University of Michigan, Ann Arbor
City of Hope, Duarte
Fudan University Shanghai Cancer Center, Shanghai
The First Affiliated Hospital of Anhui Medical University, Hefei
Zhejiang Cancer Hospital, Hangzhou
Taizhou Hospital of Zhejiang Province, Taizhou
The Second Affiliated Hospital of Nanchang University, Nanchang
Jiangxi Cancer Hospital, Nanchang
Fujian Cancer Hospital, Fuzhou
The First Affiliated Hospital of Xiamen University, Xiamen
The Second Xiangya Hospital of Central South University, Changsha
Hunan Cancer Hospital, Changsha
The First Affiliated Hospital of University of South China, Hengyang
Hubei Cancer Hospital, Wuhan
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou
Zhujiang Hospital of Southern Medical University, Guangzhou
Nanfang Hospital, Southern Medical University, Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou
Guangzhou Panyu Central Hospital, Guangzhou
Cancer Hospital of Shantou University Medical College, Shantou
Shenzhen People's Hospital, Shenzhen
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai
Dongguan People's Hospital, Dongguan
Affiliated Hospital of Guangdong Medical University, Zhanjiang
Jiangmen Central Hospital, Jiangmen
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning
Guangxi Medical University Cancer Hospital, Nanning
The First Affiliated Hospital of Guangxi Medical University, Nanning
Affiliated Hospital of Guilin Medical University, Guilin
Guizhou Cancer Hospital, Guiyang
The First Affiliated Hospital of Hainan Medical University, Haikou
Hainan General Hospital, Haikou
Sichuan Cancer Hospital, Chengdu
The Affiliated Hospital of Southwest Medical University, Luzhou
Yunnan Cancer Hospital, Kunming
Chris O'Brien Lifehouse, Camperdown
Hospital de Câncer de Barretos - Fundação Pio XII, Barretos
Grupo Oncoclínicas, Botafogo
Hospital Bruno Born, Lajeado
Hospital Nossa Senhora da Conceicao, Porto Alegre
Centro de Estudos e Pesquisa de Hematologia, Santo André
Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo
Centro de Câncer A. C. Camargo, São Paulo
Alberta Health Services (Tom Baker Cancer Centre), Calgary
Toronto Sunnybrook Hospital, Toronto
Lead Sponsor
Akeso
INDUSTRY