A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC
- Conditions
- Lung Cancer Squamous CellLung Cancer Stage IVPD-1 AntibodyChemotherapy Effect
- Interventions
- Drug: SHR-1210Drug: The placebo
- Registration Number
- NCT03668496
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 390
- Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) and clinical stage IV
- has not received prior systemic treatment for metastatic NSCLC.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- Has archived Tumor tissue samples
- Subject must have a measurable target lesion based on RECIST v1.1 .
- Has adequate organ function.
- 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.
- Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
- active brain metastases and meningeal metastasis
- uncontrollable tumor-related pain
- massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
- radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,
- imaging (CT or MRI) showed that the tumor invading the large vessels
- Known EGFR/ALK mutation.
- subjects with any known or suspected autoimmune diseases
- subjects with known or suspected interstitial pneumonia;
- Subjects with severe cardiovascular and cerebrovascular diseases
- arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
- female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
- positive HIV test;
- active hepatitis B
- evidence of active TB infection within 1 year before first dose;
- severe infection occurred within 4 weeks before the first dose
- patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month
- subjects who is on systemic immunogenic agents;
- a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- History of severe allergic reactions to carboplatin or paclitaxel or their preventive drugs;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-1210 +chemotherapy SHR-1210 subject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles chemotherapy The placebo carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 24 month 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 24 month defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.
Adverse events (AEs) up to 24 month All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Progression-free survival up to 24 month Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Objective Response Rate (ORR) up to 24 month The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.
disease control rate (DCR) up to 24 month The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.
Duration of response （DoR） up to 24 month According to Recist v 1.1 accessed by investigators
Trial Locations
- Locations (52)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital Of Anhui Medical University
🇨🇳Hefei, Anhui, China
Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, Hebei, China
Tangshan People's Hospital
🇨🇳Tangshan, Hebei, China
The Third Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
🇨🇳Kunming, Yunnan, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital ZheJiang University School Of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sichuan Provincial Cancer Hospital
🇨🇳Chengdu, Sichuan, China
The Fifth Medical Center of PLA Ceneral Hospital
🇨🇳Beijing, Beijing, China
The Seventh Medical Center of PLA Ceneral Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
🇨🇳Shijiazhuang, Hebei, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of Hust
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
LinYi Cancer Hospital
🇨🇳Linyi, Shandong, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital，ZheJiang University
🇨🇳Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital
🇨🇳HangZhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
900TH Hospital of Joint Logistics Support Force
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Xiang yang Central Hospital
🇨🇳Xiangyang, Hubei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shanghai Pulmonary Hospital, Tongji University
🇨🇳Shanghai, Shanghai, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shaanxi Provincial Cancer Hospital
🇨🇳Xian, Shanxi, China
The Second Affiliated Hospital of Zhejiang University of Medicine
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China