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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 2

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: SHR-1210

Study type: Interventional

Funder types: Other

Identifiers

NCT04790539

ES-SCLC-1st-IIT-SHR1210-naP-CB

Details and patient eligibility

About

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

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

SHR-1210+Paclitaxel-albumin+Carboplatin

Experimental group

Description:

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.

Treatment:

Drug: SHR-1210