A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC
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
1 other identifier
interventional
390
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2018
Typical duration for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
November 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 15, 2021
March 1, 2021
2 years
September 11, 2018
March 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Progression-free survival
up to 24 month
Overall Survival (OS)
up to 24 month
Objective Response Rate (ORR)
up to 24 month
disease control rate (DCR)
up to 24 month
Duration of response （DoR）
up to 24 month
- +1 more secondary outcomes
Study Arms (2)
SHR-1210 +chemotherapy
EXPERIMENTALsubject 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
ACTIVE COMPARATORcarboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles
Interventions
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.
in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Anhui Provincial Hospital
Hefei, Anhui, 230036, China
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230036, China
Anhui Chest Hospital
Hefei, Anhui, MD, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000, China
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, 100000, China
The Seventh Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
900TH Hospital of Joint Logistics Support Force
Fuzhou, Fujian, 350001, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Jieyang People's Hospital
Jieyang, Guangdong, 522000, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000, China
The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
Shijiazhuang, Hebei, 50000, China
Tangshan People's Hospital
Tangshan, Hebei, 63001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Hubei Cancer Hospital
Wuhan, Hubei, 430000, China
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, 430000, China
Xiang yang Central Hospital
Xiangyang, Hubei, 441000, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, 410013, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130012, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130012, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
LinYi Cancer Hospital
Linyi, Shandong, 276001, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai Pulmonary Hospital, Tongji University
Shanghai, Shanghai Municipality, 200433, China
Baoji Central Hospital
Baoji, Shanxi, 721000, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000, China
Shaanxi Provincial Cancer Hospital
Xian, Shanxi, 710061, China
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, 610000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, 650118, China
The First Affiliated Hospital，ZheJiang University
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital ZheJiang University School Of Medicine
Hangzhou, Zhejiang, 310018, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The Second Affiliated Hospital of Zhejiang University of Medicine
Hangzhou, Zhejiang, 310052, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
Related Publications (2)
Jiang T, Chen J, Xu X, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Zhang Y, Zhang J, Yang Z, Shi W, Zou J, Zhou C, Ren S. On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial. Mol Cancer. 2022 Jan 3;21(1):4. doi: 10.1186/s12943-021-01479-4.
PMID: 34980131DERIVEDRen S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. doi: 10.1016/j.jtho.2021.11.018. Epub 2021 Dec 16.
PMID: 34923163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jianjun Zou, MD, PhD
Jiangsu HengRui Medicine Co., Ltd.
- PRINCIPAL INVESTIGATOR
Caicun Zhou, MD, PhD
Tongji University, Shanghai Pulmonary Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 12, 2018
Study Start
November 9, 2018
Primary Completion
November 6, 2020
Study Completion
December 31, 2021
Last Updated
March 15, 2021
Record last verified: 2021-03