Clinical trial NCT04316364: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-20
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Major pathological response rate (MPR)
timeFrame: At time of surgery
measure: Event free survival (EFS)
timeFrame: Approximately 66 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately 96 months
measure: Pathology complete response (pCR)
timeFrame: At time of surgery
measure: Objective response rate (ORR)
timeFrame: prior to surgery
measure: Disease-Free Survival (DFS)
timeFrame: Approximately 66 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: JiangSu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: ZheJiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: YILONG WU, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: