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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Criteria

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