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

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04790539
• Other study ID #: ES-SCLC-1st-IIT-SHR1210-naP-CB
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Caicun Zhou, PhD
• Email: caicunzhoudr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: December 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Response Rate (ORR)	Determined using RECIST v1.1 criteria	Up to approximately 24 months
Secondary	Progression-Free Survival(PFS)	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 approximately 24 months
Secondary	Overall Survival(OS)	Defined as the time from randomization to death from any cause	Up to approximately 24 months
Secondary	Number of Subjects with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0	Up to approximately 24 months