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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03668496
Other study ID # SHR-1210-III-307
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 9, 2018
Est. completion date December 31, 2021

Study information

Verified date March 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.


Description:

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 390
Est. completion date December 31, 2021
Est. primary completion date November 6, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) and clinical stage IV 2. has not received prior systemic treatment for metastatic NSCLC. 3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status 4. Has archived Tumor tissue samples 5. Subject must have a measurable target lesion based on RECIST v1.1 . 6. Has adequate organ function. 7. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug. 8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed. Exclusion Criteria: 1. active brain metastases and meningeal metastasis 2. uncontrollable tumor-related pain 3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage; 4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose, 5. imaging (CT or MRI) showed that the tumor invading the large vessels 6. Known EGFR/ALK mutation. 7. subjects with any known or suspected autoimmune diseases 8. subjects with known or suspected interstitial pneumonia; 9. Subjects with severe cardiovascular and cerebrovascular diseases 10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months; 11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period; 12. positive HIV test; 13. active hepatitis B 14. evidence of active TB infection within 1 year before first dose; 15. severe infection occurred within 4 weeks before the first dose 16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month 17. subjects who is on systemic immunogenic agents; 18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins; 19. History of severe allergic reactions to carboplatin or paclitaxel or their preventive drugs;

Study Design


Intervention

Drug:
SHR-1210
Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
The placebo
in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

Locations

Country Name City State
China Baoji Central Hospital Baoji Shanxi
China Beijing Cancer Hospital Beijing Beijing
China Beijing Cancer Hospital Beijing Beijing
China The Fifth Medical Center of PLA Ceneral Hospital Beijing Beijing
China The Seventh Medical Center of PLA Ceneral Hospital Beijing Beijing
China China-Japan Union Hospital of Jilin University Changchun Jilin
China Jilin Cancer Hospital Changchun Jilin
China The First Bethune Hospital of Jilin University Changchun Jilin
China Hunan Cancer Hospital Changsha Hunan
China The Second Xiangya Hospital Of Central South University Changsha Hunan
China The Third Xiangya Hospital Of Central South University Changsha Hunan
China Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi
China Affiliated Hospital of Chengde Medical College Chengde Hebei
China Sichuan Provincial Cancer Hospital Chengdu Sichuan
China Chongqing University Cancer Hospital Chongqing Chongqing
China 900TH Hospital of Joint Logistics Support Force Fuzhou Fujian
China Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou Guangdong
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China Sir Run Run Shaw Hospital ZheJiang University School Of Medicine Hangzhou Zhejiang
China The First Affiliated Hospital,ZheJiang University Hangzhou Zhejiang
China The Second Affiliated Hospital of Zhejiang University of Medicine Hangzhou Zhejiang
China ZheJiang Cancer Hospital HangZhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Anhui Chest Hospital Hefei Anhui
China Anhui Provincial Hospital Hefei Anhui
China The Second Affiliated Hospital Of Anhui Medical University Hefei Anhui
China Jieyang People's Hospital Jieyang Guangdong
China Jinan Central Hospital Jinan Shandong
China Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Kunming Yunnan
China LinYi Cancer Hospital Linyi Shandong
China Jiangxi Cancer Hospital Nanchang Jiangxi
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Jiangsu Province Hospital Nanjing Jiangsu
China Nanjing Drum Tower Hospital Nanjing Jiangsu
China Shanghai Changhai Hospital Shanghai Shanghai
China Shanghai Pulmonary Hospital, Tongji University Shanghai Shanghai
China The First Hospital of China Medical University Shenyang Liaoning
China The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital) Shijiazhuang Hebei
China Shanxi Provincial People's Hospital Taiyuan Shanxi
China Taizhou Hospital of Zhejiang Province Taizhou Zhejiang
China Tangshan People's Hospital Tangshan Hebei
China Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin
China Hubei Cancer Hospital Wuhan Hubei
China Tongji Hospital, Tongji Medical College of Hust Wuhan Hubei
China Affiliated Hospital of Jiangnan University Wuxi Jiangsu
China Shaanxi Provincial Cancer Hospital Xian Shanxi
China Xiang yang Central Hospital Xiangyang Hubei
China Northern Jiangsu People's Hospital Yangzhou Jiangsu
China Henan Cancer Hospital Zhengzhou Henan
China Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Affiliated Hospital of Zunyi Medical University Zunyi Guizhou

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first. up to 24 month
Secondary Progression-free survival Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1 up to 24 month
Secondary Overall Survival (OS) defined as time from the randomized to the time of the patient's death from any reason assessed by researchers. up to 24 month
Secondary Objective Response Rate (ORR) The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1. up to 24 month
Secondary disease control rate (DCR) The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1. up to 24 month
Secondary Duration of response (DoR) According to Recist v 1.1 accessed by investigators up to 24 month
Secondary Adverse events (AEs) All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03 up to 24 month
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