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

Director of Shandong Cancer Hospital and Institute

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive-stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: SHR1316; Drug: Chemotherapy; Drug: Chemotherapy; Radiation: Radiation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 67
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinming Yu, PhD; Phone Number: +8613806406293; Email: jn7984729@public.jn.sd.cn

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:

• 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

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: SHR1316+Chemotherapy +Radiotherapy; Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy	Drug: SHR1316; Anti-PD-L1 antibody; Drug: Chemotherapy; Carboplatin; Drug: Chemotherapy; etoposide; Radiation: Radiation therapy; thoracic radiation therapy ,TRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival （OS）	Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival (PFS)	Up to approximately 36 months
Objective Response Rate (ORR)	Up to approximately 36 months
disease control rate (DCR)	Up to approximately 36 months
Duration of Response (DOR)	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: SHR1316, Chemotherapy, Radiotherapy
• 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-SHR1316-CRT

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