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

Primary Purpose

Non-Small-Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
SHR-1316、Chemotherapeutic
Placebo、Chemotherapeutic
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • JiangSu Cancer HospitalRecruiting
  • Zhongshan Hospital, Fudan UniversityRecruiting
  • West China Hospital,Sichuan UniversityRecruiting
  • ZheJiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Arm Description

Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles

Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles

Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles

Outcomes

Primary Outcome Measures

Major pathological response rate (MPR)
Event free survival (EFS)

Secondary Outcome Measures

Overall survival (OS)
Pathology complete response (pCR)
Objective response rate (ORR)
Disease-Free Survival (DFS)

Full Information

First Posted
March 19, 2020
Last Updated
October 27, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04316364
Brief Title
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
537 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
Arm Title
Treatment group B
Arm Type
Experimental
Arm Description
Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
Arm Title
Treatment group C
Arm Type
Placebo Comparator
Arm Description
Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles
Intervention Type
Drug
Intervention Name(s)
SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SHR-1316、Chemotherapeutic
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo、Chemotherapeutic
Intervention Description
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
Primary Outcome Measure Information:
Title
Major pathological response rate (MPR)
Time Frame
At time of surgery
Title
Event free survival (EFS)
Time Frame
Approximately 66 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Approximately 96 months
Title
Pathology complete response (pCR)
Time Frame
At time of surgery
Title
Objective response rate (ORR)
Time Frame
prior to surgery
Title
Disease-Free Survival (DFS)
Time Frame
Approximately 66 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Shi, MD
Phone
+86 010-67166319
Email
wei.shi@hengrui.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YILONG WU, M.D, PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Keneng
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenzhao Zhong
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqun Xing
Facility Name
JiangSu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Zhang
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Ge
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lunxu Liu
Facility Name
ZheJiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qixun Chen

12. IPD Sharing Statement

Learn more about this trial

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

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