This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
6-month PFS rate
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
Time frame: up to 24 months
Overall Response Rate (ORR)
Determined using RECIST v1.1 criteria
Time frame: Up to approximately 24 months
Progression-Free Survival(PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Time frame: Up to approximately 24 months
Overall Survival(OS)
Defined as the time from randomization to death from any cause
Time frame: Up to approximately 24 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0
Time frame: Up to approximately 24 months
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