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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin; Drug: SHR-1316、Chemotherapeutic; Drug: Placebo、Chemotherapeutic

• Study Type: Interventional
• Enrollment (Anticipated): 537
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vivian Shi, MD; Phone Number: +86 010-67166319; Email: wei.shi@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Chen Keneng
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Wenzhao Zhong
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Wenqun Xing
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Di Ge
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital，Sichuan University
      • Contact: Lunxu Liu
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Qixun Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: Treatment group B; Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles	Drug: 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 Comparator: Treatment group C; Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major pathological response rate (MPR)	At time of surgery
Event free survival (EFS)	Approximately 66 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Approximately 96 months
Pathology complete response (pCR)	At time of surgery
Objective response rate (ORR)	prior to surgery
Disease-Free Survival (DFS)	Approximately 66 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: YILONG WU, M.D, PhD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): December 15, 2026

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: SHR-1316-III-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No