A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Recruiting
Phase 3Interventional Study
Non-Small-Cell Lung Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
537 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Who this trial is looking for
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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.
Trial Locations
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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 …
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.
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