Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

Official Title

A Phase III, Open-label, Multicentre Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer

Summary:

The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumours

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) in Subjects With High PD-L1 + Tumour Expression Based on an Independent Review Committee (IRC) Assessment According to RECIST 1.1
  • Overall Survival (OS) in Subjects With High PD-L1 + Tumour Expression
Secondary Outcome:
  • Progression Free Survival (PFS) in Subjects With Moderate and High PD-L1 + Tumour Expression Based on an IRC Assessment According to RECIST 1.1
  • Overall Survival (OS) in Subjects With Moderate and High and any PD-L1 + Tumour Expression
  • Best Overall Response (BOR) as Adjudicated by the IRC
  • Duration of Response (DOR) According to RECIST 1.1
  • Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire
  • Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status
  • Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
  • Number of Subjects With Abnormalities in Safety Laboratory Tests as Graded by NCI-CTCAE (Version 4.03)
  • Number of Subjects With Abnormalities in Vital Signs, Physical Examination, and Eastern Cooperative Oncology Group (ECOG) PS.
  • Number of Subjects With Abnormalities in 12-lead ECG

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society