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

This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer focused on measuring SHR1316, Chemotherapy, Radiotherapy Read More

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