This study was a single-arm, multi-center, phase II study, which is aimed to evaluate the efficacy and safety of CM082 combined with JS001 as the second-line treatment of advanced small cell lung cancer. Eligible patients will receive CM082 tablets 150mg once daily orally in combination with JS001 (240mg, intravenously) every 21 days. Treatment continues until disease progresses , intolerable toxicity, or withdraw.
This study was a single-arm, multi-center, phase II study, which is aimed to evaluate the efficacy and safety of CM082 combined with JS001 as the second-line treatment of advanced small cell lung cancer. Eligible patients will receive CM082 tablets 150mg once daily orally in combination with JS001 (240mg, intravenously) every 21 days. Treatment continues until disease progresses , intolerable toxicity, or withdraw. The primary endpoint is tumor response per investigator assessment according to response evaluation criteria in solid tumors (recist) version 1.1, secondary endpoints include disease control rate, progression-free survival, overall survival, safety and tolerability. iRECIST is also implemented for tumor response assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CM082: 150mg once a day orally (taken within half an hour after breakfast) JS001: An intravenous infusion of a solution having a concentration of 1-3mg/ml was prepared with 0.9% physiological saline, and administered once every three weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.
National Cancer Center/Cancer Hospital
Beijing, China
NOT_YET_RECRUITINGThe First Hospital of China Medical University
Shenyang, China
RECRUITINGObjective Response Rate
The proportion of patients with complete remission (CR) and partial remission (PR) in all patients. Disease progression will be evaluated according to RECIST 1.1.
Time frame: 6 months
Progression-free survival
The internal between the date of enrollment and the date of disease progression, unaccepted toxicity, or death according to RECIST 1.1 and iRECIST.
Time frame: 12 months
Overall survival
The internal between the date of randomization and the date of death
Time frame: 36 months
Disease Control Rate
The proportion of patients with complete remission (CR), partial remission (PR) and stable disease (SD) in all patients. Disease progression will be evaluated according to RECIST 1.1 and iRECIST.
Time frame: 6 months
Duration of Response
The time between patients's first time to complete or partial remission to disease progression.
Time frame: 12 months
Time to response
The internal between the date of enrollment and the date of documented tumor response
Time frame: 12 months
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