Chemotherapy Effect Clinical Trial
Official title:
A Phase III, Randomized,Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of SHR-1210 in Combination With Carboplatin and Paclitaxel Versus Placebo in Combination With Carboplatin and Paclitaxel in First-Line Stage IV Squamous Non-Small Cell Lung Cancer
Verified date | March 2021 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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; |
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 |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
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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