An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 18\
⁃ 75 years old, both male and female
• Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
• Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS \<50% as confirmed by central laboratory
• At least one measurable lesion based on RECIST v1.1 criteria
• ECOG PS score: 0-1 points
• Expected survival period ≥ 3 months
• Good levels of organ function
• Patients voluntarily joined the study and signed informed consent
Locations
Other Locations
China
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
West China Hospital Of Sichuan University
NOT_YET_RECRUITING
Chengdu
Cancer Hospital Affiliated to Chongqing University
NOT_YET_RECRUITING
Chongqing
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Chest Hospital
NOT_YET_RECRUITING
Hefei
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Affiliated Tumor Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Jiangsu Cancer Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Jiangnan University
NOT_YET_RECRUITING
Wuxi
Xiangyang Central Hospital
NOT_YET_RECRUITING
Xiangyang
North Jiangsu People's Hospital
NOT_YET_RECRUITING
Yangzhou
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Xin Xu
xin.xu@hengrui.com
0518-82342973
Backup
Weixia Li
weixia.li@hengrui.com
0518-82342973
Time Frame
Start Date:2022-08-15
Estimated Completion Date:2026-06-30
Participants
Target number of participants:168
Treatments
Experimental: SHR-8068 in combination with adebrelimab
Experimental: SHR-8068 in combination with adebrelimab and platinum-based chemotherapy
Experimental: Adebrelimab in combination with platinum-based chemotherapy