This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
SHR-7787 injection.
SHR-1316 (Adebrelimab) Injection.
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Incidence and severity of adverse events (AEs)
The dose expansion part of Phase 1
Time frame: Approximately 3 weeks
Incidence and severity of serious adverse events (SAEs)
The dose expansion part of Phase 1
Time frame: Approximately 3 weeks
Progression-Free Survival (PFS)
The dose expansion part of Phase 1
Time frame: Approximately 16 months
Progression-Free Survival (PFS)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Overall Survival (OS)
The dose expansion part of Phase 1
Time frame: Approximately 16 months
Objective Response Rate (ORR)
The dose expansion part of Phase 1
Time frame: Approximately 16 months
Duration of Response (DoR)
The dose expansion part of Phase 1
Time frame: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
The dose expansion part of Phase 1
Time frame: Approximately 16 months
Disease Control Rate (DCR)
The dose expansion part of Phase 1
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Time frame: Approximately 16 months
Disease Control Rate (DCR)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Overall Survival (OS)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Objective Response Rate (ORR)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Duration of Response (DoR)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Incidence and severity of adverse events (AEs)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months
Incidence and severity of serious adverse events (SAEs)
The efficacy expansion part of Phase 2
Time frame: Approximately 16 months