A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03668496
• Other study ID #: SHR-1210-III-307
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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;

Related Conditions & MeSH terms

• Chemotherapy Effect
• Lung Cancer Squamous Cell
• Lung Cancer Stage IV
• Lung Neoplasms
• PD-1 Antibody

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