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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04316364

Collaborator

(none)

537

Enrollment

Locations

Arms

Anticipated Duration (Months)

76.7

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer	Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin Drug: SHR-1316、Chemotherapeutic Drug: Placebo、Chemotherapeutic	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

537 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 14, 2020

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Dec 15, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Major pathological response rate (MPR) [At time of surgery]
Event free survival (EFS) [Approximately 66 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100000
2	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510000
3	Henan Cancer Hospital	Zhengzhou	Henan	China	450000
4	JiangSu Cancer Hospital	Nanjing	Jiangsu	China	210009
5	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
6	West China Hospital,Sichuan University	Chengdu	Sichuan	China	610041
7	ZheJiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

Principal Investigator: YILONG WU, M.D, PhD, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04316364

Other Study ID Numbers:

SHR-1316-III-303

First Posted:

Mar 20, 2020

Last Update Posted:

Nov 4, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Paclitaxel

Carboplatin

Study Results

No Results Posted as of Nov 4, 2021