Clinical Research Details

Descriptive Information
A Phase III, Open-label, Multicenter 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

Arafat Tfayli

EMR 100070-005

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

  • EMD Serono Research & Development Institute, Inc.
Conditions and Keywords
Lung cancer
Study Design
Eligibility and IRB
Min: 18

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+) tumors. 

Inclusion Criteria:

  • Male or female subjects aged greater than or equal to (>=) 18 years
  • With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  • At least 1 measurable tumor lesion
  • With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
  • With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
  • Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
  • Other protocol defined criteria could apply

Exclusion Criteria:

  • Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
  • Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03.
  • Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
  • Other protocol defined criteria could apply