A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
NCT ID: NCT04316364
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
537 participants
INTERVENTIONAL
2020-07-14
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group A
Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
Treatment group B
Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
SHR-1316、Chemotherapeutic
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Treatment group C
Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles
Placebo、Chemotherapeutic
Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Interventions
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SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
SHR-1316、Chemotherapeutic
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Placebo、Chemotherapeutic
Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Eligibility Criteria
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Inclusion Criteria
* Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
* Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
* Measurable disease as defined by RECIST v1.1
* Adequate organ function
* Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment
Exclusion Criteria
* With active, known or suspected autoimmune disease of autoimmune disease
* Malignancies other than NSCLC within 5 years prior to randomization
* Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
* Significant history of cardiovascular and cerebrovascular disease
* Significant haemorrhagic disease
* Has an arteriovenous thrombotic events
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known active Hepatitis B or Hepatitis C
* Allergic to monoclonal antibodies or other protein drugs
* Allergic to the intervention regimens
* Pregnant or lactating women
* Has known psychiatric or substance abuse disorders
* Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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YILONG WU, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
JiangSu Cancer Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chen Keneng
Role: primary
Wenzhao Zhong
Role: primary
Wenqun Xing
Role: primary
Qin Zhang
Role: primary
Di Ge
Role: primary
Lunxu Liu
Role: primary
Qixun Chen
Role: primary
Other Identifiers
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SHR-1316-III-303
Identifier Type: -
Identifier Source: org_study_id