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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: SHR-1210

• Study Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Caicun Zhou, PhD; Email: caicunzhoudr@126.com
• Study Contact Backup: Name: Shengxiang Ren, PhD; Email: harry_ren@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: SHR-1210; SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody; Other Names: Anti-PD-1 Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Determined using RECIST v1.1 criteria	Up to approximately 24 months
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
Overall Survival(OS)	Defined as the time from randomization to death from any cause	Up to approximately 24 months
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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 7, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ES-SCLC-1st-IIT-SHR1210-naP-CB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No