Back to resultsA Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC
Primary Purpose
Lung Cancer Squamous Cell, Lung Cancer Stage IV, PD-1 Antibody
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1210
The placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer Squamous Cell
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Sites / Locations
- Anhui Provincial Hospital
- The Second Affiliated Hospital Of Anhui Medical University
- Anhui Chest Hospital
- Beijing Cancer Hospital
- The Fifth Medical Center of PLA Ceneral Hospital
- The Seventh Medical Center of PLA Ceneral Hospital
- Beijing Cancer Hospital
- Chongqing University Cancer Hospital
- 900TH Hospital of Joint Logistics Support Force
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
- The First Affiliated Hospital of Guangzhou Medical University
- Nanfang Hospital, Southern Medical University
- Jieyang People's Hospital
- Affiliated Hospital of Zunyi Medical University
- Affiliated Hospital of Chengde Medical College
- The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
- Tangshan People's Hospital
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Henan Provincial People's Hospital
- Hubei Cancer Hospital
- Tongji Hospital, Tongji Medical College of Hust
- Xiang yang Central Hospital
- Hunan Cancer Hospital
- The Second Xiangya Hospital Of Central South University
- The Third Xiangya Hospital Of Central South University
- Jiangsu Province Hospital
- Nanjing Drum Tower Hospital
- Affiliated Hospital of Jiangnan University
- Northern Jiangsu People's Hospital
- Jiangxi Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- China-Japan Union Hospital of Jilin University
- Jilin Cancer Hospital
- The First Bethune Hospital of Jilin University
- The First Hospital of China Medical University
- Jinan Central Hospital
- LinYi Cancer Hospital
- Shanghai Changhai Hospital
- Shanghai Pulmonary Hospital, Tongji University
- Baoji Central Hospital
- Heping Hospital Affiliated to Changzhi Medical College
- Shanxi Provincial People's Hospital
- Shaanxi Provincial Cancer Hospital
- Sichuan Provincial Cancer Hospital
- Tianjin Medical University Cancer Institute and Hospital
- Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
- The First Affiliated Hospital，ZheJiang University
- Sir Run Run Shaw Hospital ZheJiang University School Of Medicine
- ZheJiang Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University of Medicine
- Taizhou Hospital of Zhejiang Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SHR-1210 +chemotherapy
chemotherapy
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression-free survival
Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Overall Survival (OS)
defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.
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.
Duration of response （DoR）
According to Recist v 1.1 accessed by investigators
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Full Information
NCT ID
NCT03668496
First Posted
September 11, 2018
Last Updated
March 12, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03668496
Brief Title
A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Squamous Cell, Lung Cancer Stage IV, PD-1 Antibody, Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210 +chemotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
The placebo
Intervention Description
in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
up to 24 month
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Time Frame
up to 24 month
Title
Overall Survival (OS)
Description
defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.
Time Frame
up to 24 month
Title
Objective Response Rate (ORR)
Description
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.
Time Frame
up to 24 month
Title
disease control rate (DCR)
Description
The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.
Time Frame
up to 24 month
Title
Duration of response （DoR）
Description
According to Recist v 1.1 accessed by investigators
Time Frame
up to 24 month
Title
Adverse events (AEs)
Description
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Time Frame
up to 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianjun Zou, MD, PhD
Organizational Affiliation
Jiangsu HengRui Medicine Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD, PhD
Organizational Affiliation
Tongji University, Shanghai Pulmonary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Facility Name
The Second Affiliated Hospital Of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
MD
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The Fifth Medical Center of PLA Ceneral Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The Seventh Medical Center of PLA Ceneral Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
900TH Hospital of Joint Logistics Support Force
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Jieyang People's Hospital
City
Jieyang
State/Province
Guangdong
ZIP/Postal Code
522000
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563003
Country
China
Facility Name
Affiliated Hospital of Chengde Medical College
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067000
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50000
Country
China
Facility Name
Tangshan People's Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
63001
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Hust
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Xiang yang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441000
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
The Second Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Third Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
LinYi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276001
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanghai Pulmonary Hospital, Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shanxi
ZIP/Postal Code
721000
Country
China
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
State/Province
Shanxi
ZIP/Postal Code
046000
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Shaanxi Provincial Cancer Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Sichuan Provincial Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
The First Affiliated Hospital，ZheJiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital ZheJiang University School Of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
ZheJiang Cancer Hospital
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34980131
Citation
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.
Results Reference
derived
PubMed Identifier
34923163
Citation
Ren 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.
Results Reference
derived
Learn more about this trial
A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC
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