A Phase II Clinical Study of SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in Extensive Small Cell Lung Cancer

Extensive-stage Small Cell Lung Cancer Clinical Trial

Official title:

Director of Shandong Cancer Hospital and Institute

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04562337
• Other study ID #: ES-SCLC-1st-IIT-SHR1316-CRT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: JinMing Yu, PhD
• Phone: +8613806406293
• Email: jn7984729[@]public.jn.sd.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of shr1316 combined with chest radiotherapy after induction therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Extensive small cell lung cancer

• Eastern Cooperative Oncology Group performance status (PS) of 0 to 1

• 18 to 75 years old

• The function of vital organs meets the following requirements. WBC = 3.0 × 109/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 times ULN or CCr=60mL/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

• Measurable lesions outside of the field of chest radiotherapy(iRECIST)

• Signed written informed consent prior to study entry

Exclusion Criteria:

• Active or untreated CNS metastases

• 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.

• Failing to properly control the clinical symptoms or disease of the heart

• 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 cisplatin or etoposide

• 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:
• SHR1316
Anti-PD-L1 antibody
• Chemotherapy
Carboplatin
• Chemotherapy
etoposide

Radiation:
• Radiation therapy
thoracic radiation therapy ,TRT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)		Up to approximately 36 months
Secondary	progression-free survival (PFS)		Up to approximately 36 months
Secondary	Objective Response Rate (ORR)		Up to approximately 36 months
Secondary	disease control rate (DCR)		Up to approximately 36 months
Secondary	Duration of Response (DOR)		Up to approximately 36 months