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

NCT04316364 · tracked via the Priya Life Science China tracker

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Phase

Phase 3

Started

2020-07-14

Last updated

2021-11-04

Condition(s) studied

Non-Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

SHR-1316、Paclitaxel (Albumin Bound)、CarboplatinSHR-1316、ChemotherapeuticPlacebo、Chemotherapeutic

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

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

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.

Primary outcome measure(s)

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

Trial sites (7)

Facility	City	Region	Status
Beijing Cancer Hospital	Beijing	Beijing Municipality	Recruiting
Guangdong Provincial People's Hospital	Guangzhou	Guangdong	Recruiting
Henan Cancer Hospital	Zhengzhou	Henan	Recruiting
JiangSu Cancer Hospital	Nanjing	Jiangsu	Recruiting
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
West China Hospital,Sichuan University	Chengdu	Sichuan	Recruiting
ZheJiang Cancer Hospital	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04316364 on ClinicalTrials.gov ↗ ← All trials in China