A Phase II Clinical Study of SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in Extensive Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of shr1316 combined with chest radiotherapy after induction therapy.

Official Title
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Director of Shandong Cancer Hospital and Institute

Conditions
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Extensive-stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: SHR1316
* Drug: Chemotherapy
* Drug: Chemotherapy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of Extensive small cell lung cancer Eastern Cooperative Oncology Group performance status (PS) of 0 to 1 18 to 75 years old The function of vital organs meets the following requirements. WBC ≥ 3.0 × 109/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 times ULN or CCr≥60mL/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 Measurable lesions outside of the field of chest radiotherapy(iRECIST) Signed written informed consent prior to study entry Exclusion Criteria: Active or untreated CNS metastases 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. Failing to properly control the clinical symptoms or disease of the heart 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 cisplatin or etoposide 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: SHR1316+Chemotherapy +Radiotherapy<br>Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy | Drug: SHR1316<br>* Anti-PD-L1 antibody<br>Drug: Chemotherapy<br>* Carboplatin<br>Drug: Chemotherapy<br>* etoposide<br>Radiation: Radiation therapy<br>* thoracic radiation therapy ,TRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival （OS） |  | Up to approximately 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) |  | Up to approximately 36 months | 
| Objective Response Rate (ORR) |  | Up to approximately 36 months | 
| disease control rate (DCR) |  | Up to approximately 36 months | 
| Duration of Response (DOR) |  | Up to approximately 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR1316, Chemotherapy, Radiotherapy