A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316364
• Other study ID #: SHR-1316-III-303
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: December 15, 2026

Study information

• Verified date: October 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Vivian Shi, MD
• Phone: +86 010-67166319
• Email: wei.shi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 537
• Est. completion date: December 15, 2026
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• 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:

• Any previous systematic anti-cancer therapy for lung cancer

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	ZheJiang Cancer Hospital	Hangzhou	Zhejiang
China	JiangSu Cancer Hospital	Nanjing	Jiangsu
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan

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	Major pathological response rate (MPR)		At time of surgery
Primary	Event free survival (EFS)		Approximately 66 months
Secondary	Overall survival (OS)		Approximately 96 months
Secondary	Pathology complete response (pCR)		At time of surgery
Secondary	Objective response rate (ORR)		prior to surgery
Secondary	Disease-Free Survival (DFS)		Approximately 66 months