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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.