CompletedPhase 3NCT02576574

Avelumab in First-line NSCLC (JAVELIN Lung 100)

The purpose of this study was 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) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Checked against the public recordLast updated Jan 31, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations349
SponsorEMD Serono Research & Development Institute, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
EMD Serono Research & Development Institute, Inc.
Interventions being studied
Drug: Avelumab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin; Drug: Carboplatin; Drug: Avelumab Weekly
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Clearview Cancer InstituteHuntsville, Alabama
  • Arizona Center for Cancer CareSurprise, Arizona
  • Sharp Memorial HospitalSan Diego, California
  • University Cancer InstituteBoynton Beach, Florida
  • South Georgia Medical CenterValdosta, Georgia
  • Christus Cancer Treatment CenterShreveport, Louisiana
  • Henry Ford HospitalDetroit, Michigan
  • St. Vincent Frontier Cancer CenterBillings, Montana
  • Nevada Cancer Research FoundationLas Vegas, Nevada
  • San Juan Oncology AssociatesFarmington, New Mexico
  • Novant Health Oncology SpecialistsKernersville, North Carolina
  • Mercy ResearchOklahoma City, Oklahoma

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 31, 2025. Always confirm current availability with the study team.

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