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

NCT04790539 | Unknown Phase 2

• 1 other identifier: ES-SCLC-1st-IIT-SHR1210-naP-CB
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 6-month PFS rate

  PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment

  up to 24 months

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Up to approximately 24 months

• Progression-Free Survival(PFS)

  Up to approximately 24 months

• Overall Survival(OS)

  Up to approximately 24 months

• Number of Subjects with treatment-related adverse events (AEs)

  Up to approximately 24 months

Study Arms (1)

SHR-1210+Paclitaxel-albumin+Carboplatin

EXPERIMENTAL

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.

Drug: SHR-1210

Interventions

SHR-1210 DRUG

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

Also known as: Anti-PD-1 Antibody

SHR-1210+Paclitaxel-albumin+Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

camrelizumab; spartalizumab

Central Study Contacts

Caicun Zhou, PhD

CONTACT

caicunzhoudr@126.com

Shengxiang Ren, PhD

CONTACT

harry_ren@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Caicun Zhou

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 31, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03