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

NCT ID: NCT03668496

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR-1210 +chemotherapy

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

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

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.

chemotherapy

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

Group Type: ACTIVE_COMPARATOR

The placebo

Intervention Type: DRUG

in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

Interventions

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.

Intervention Type: DRUG

The placebo

in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianjun Zou, MD, PhD

Role: STUDY_DIRECTOR

Jiangsu HengRui Medicine Co., Ltd.

Caicun Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji University, Shanghai Pulmonary Hospital

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

Anhui Chest Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Fifth Medical Center of PLA Ceneral Hospital

Beijing, Beijing Municipality, China

The Seventh Medical Center of PLA Ceneral Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

900TH Hospital of Joint Logistics Support Force

Fuzhou, Fujian, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Jieyang People's Hospital

Jieyang, Guangdong, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Affiliated Hospital of Chengde Medical College

Chengde, Hebei, China

The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)

Shijiazhuang, Hebei, China

Tangshan People's Hospital

Tangshan, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 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

Hubei Cancer Hospital

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China

Xiang yang Central Hospital

Xiangyang, Hubei, 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

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 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

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

The First Hospital of China Medical University

Shenyang, Liaoning, China

Jinan Central Hospital

Jinan, Shandong, China

LinYi Cancer Hospital

Linyi, Shandong, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Baoji Central Hospital

Baoji, Shanxi, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Shaanxi Provincial Cancer Hospital

Xian, Shanxi, China

Sichuan Provincial Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, China

The First Affiliated Hospital，ZheJiang University

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

Hangzhou, Zhejiang, China

ZheJiang Cancer Hospital

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University of Medicine

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34980131 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34923163 (View on PubMed)

Other Identifiers

SHR-1210-III-307

Identifier Type: -

Identifier Source: org_study_id