a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Official Title
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an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

Conditions
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Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: SHR-1210


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years old Confirmed diagnosis of Extensive small cell lung cancer Eastern Cooperative Oncology Group performance status (PS) of 0 to 1 The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN have not received first-line systemic therapy or immunosuppressive therapy for es-sclc The estimated survival period is more than 8 weeks The subjects voluntarily joined the study, signed informed consent, Exclusion Criteria: Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI); Leptomeningeal diseases Uncontrolled or symptomatic hypercalcemia Active, known or suspected autoimmune diseases have received any T cell co stimulation or immune checkpoint therapy Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug Subjects had active infections Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin According to the researcher's judgment, there are other factors that may lead to the termination of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1210+Paclitaxel-albumin+Carboplatin<br>SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip. | Drug: SHR-1210<br>* SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody<br>* Other names: Anti-PD-1 Antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Determined using RECIST v1.1 criteria | 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. | Up to approximately 24 months | 
| Overall Survival(OS) | Defined as the time from randomization to death from any cause | 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 | Up to approximately 24 months |