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Recruiting NCT04316364

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

Phase III Interventional Non-Small-Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin, SHR-1316、Chemotherapeutic, Placebo、Chemotherapeutic.
Who it may be relevant to
Registry conditions: Non-Small-Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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
  • 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
  • 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

Primary outcome measures

  • Major pathological response rate (MPR) [Time frame: At time of surgery]
  • Event free survival (EFS) [Time frame: Approximately 66 months]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: Approximately 96 months]
  • Pathology complete response (pCR) [Time frame: At time of surgery]
  • Objective response rate (ORR) [Time frame: prior to surgery]
  • Disease-Free Survival (DFS) [Time frame: Approximately 66 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 7 centers
  • Beijing Cancer Hospital — Beijing
  • Guangdong Provincial People's Hospital — Guangzhou
  • Henan Cancer Hospital — Zhengzhou
  • JiangSu Cancer Hospital — Nanjing
  • Zhongshan Hospital, Fudan University — Shanghai
  • West China Hospital,Sichuan University — Chengdu
  • ZheJiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT04316364 · SHR-1316-III-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗