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CompletedPhase 3NCT02576574
Official study title

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAvelumab and Pemetrexed

Plus 7 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?349 U.S. locations

Locations may change over time.

Who runs it?EMD Serono Research & Development Institute, Inc.

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
PD-L1→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria
  • Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
  • Other

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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