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 progression free survival (PFS) based on an Independent Review Committee (IRC) assessment of avelumab versus platinum-based doublet in non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumours.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Best Overall Response (BOR)
  • Overall Survival (OS)
  • 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

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