About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
Aged 18 to 75 years (inclusive), of any gender.
Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
ECOG performance status score of 0 or 1.
Disqualifiers
Combined small cell lung cancer or any transformed small cell lung cancer.
History of other malignancies within 5 years prior to the first dose of the study drug.
Severe cardiovascular or cerebrovascular diseases.
Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
Trial design
Single group
Treatments tested in this trial
SHR-7787 Injection
DrugSHR-7787 injection.
SHR-1316
DrugSHR-1316 (Adebrelimab) Injection.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events (AEs)
The dose expansion part of Phase 1
Incidence and severity of serious adverse events (SAEs)
The dose expansion part of Phase 1
Progression-Free Survival (PFS)
The dose expansion part of Phase 1
Progression-Free Survival (PFS)
The efficacy expansion part of Phase 2
Secondary outcomes
Overall Survival (OS)
The dose expansion part of Phase 1
Objective Response Rate (ORR)
The dose expansion part of Phase 1
Duration of Response (DoR)
The dose expansion part of Phase 1
Anti-Drug Antibody (ADA) of SHR-7787
The dose expansion part of Phase 1
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: