This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
Patients receive JS207 10mg/kg or other dosage.
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Jilin Cancer Hospital
Jilin City, Changchun, China
Objective response rate (ORR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
Time frame: 1.5years
Disease control rate (DCR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Time frame: 2years
Duration of response (DOR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Time frame: 2years
Progression-free survival (PFS)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Time frame: 1.5years
Overall survival (OS)
To evaluate overall survival (OS)
Time frame: 2years
AE
Incidence and serverity of adverse events(AE),abnormal changes in laboratory and other tests with clinical significance
Time frame: 2years
Abnormal changes in laboratory
Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance
Time frame: 2years
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Hunan Cancer Hospital
Hunan, Changsha, China
West China Hospital, Sichuan University
Sichuan, Chengdu, China
Second Affiliated Hospital, PLA Academy of Military Medical Sciences
Chongqing, Chongqing Municipality, China
Army Medical Center, PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, China
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
...and 8 more locations