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

NCT ID: NCT04790539

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-12-31

Brief 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

Conditions

Extensive Stage Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1210+Paclitaxel-albumin+Carboplatin

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.

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody

Interventions

SHR-1210

SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody

Intervention Type: DRUG

Other Intervention Names

Anti-PD-1 Antibody

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Prof. Caicun Zhou

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Caicun Zhou, PhD

Role: CONTACT

caicunzhoudr@126.com

Shengxiang Ren, PhD

Role: CONTACT

harry_ren@126.com

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id