This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SHR-1316 (sc) injection.
SHR-1316 injection.
Carboplatin injection.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
SHR-1316 serum trough concentration (Ctrough)
Time frame: Day1 pre-dose to Day28.
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
Time frame: Day1 pre-dose to Day21.
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
Time frame: Day1 pre-dose to Day28.
Maximum Concentration of SHR-1316 (sc) (Cmax)
Time frame: Day1 pre-dose to Day28.
Time to maximum plasma concentration (Tmax)
Time frame: Day1 pre-dose to Day28.
Terminal half-life (t1/2)
Time frame: Day1 pre-dose to Day28.
Incidence and severity of adverse events (AEs)
Time frame: About 2 years.
Objective Response Rate (ORR)
Time frame: About 2 years.
Duration of Relief (DoR)
Time frame: About 1.5 years.
Disease Control Rate (DCR)
Time frame: About 2 years.
Progression-free Survival (PFS)
Time frame: About 2 years.
Overall Survival (OS)
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Etoposide injection.
Time frame: About 3 years.