Avelumab in First-line NSCLC (JAVELIN Lung 100)

Completed · Phase 3

Conditions studied: First Line Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02576574

Run by

EMD Serono Research & Development Institute, Inc.

People needed

1214

Starts

2015-10-29

Expected to finish

2024-01-29

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Center for Cancer Care — Surprise, Arizona, United States
• Sharp Memorial Hospital — San Diego, California, United States
• University Cancer Institute — Boynton Beach, Florida, United States
• South Georgia Medical Center — Valdosta, Georgia, United States
• Christus Cancer Treatment Center — Shreveport, Louisiana, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Novant Health Oncology Specialists — Kernersville, North Carolina, United States
• Mercy Research — Oklahoma City, Oklahoma, United States
• Kaiser Permanente Northwest — Portland, Oregon, United States
• Lancaster Cancer Center — Lancaster, Pennsylvania, United States
• Cookeville Regional Medical Center — Cookeville, Tennessee, United States
• Thompson Cancer Survival Center — Knoxville, Tennessee, United States
• Coastal Bend Cancer Center — Corpus Christi, Texas, United States
• Oncology Consultants, P.A. — Houston, Texas, United States
• University of Vermont Medical Center — Burlington, Vermont, United States
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
• Cheyenne Regional Medical Center — Cheyenne, Wyoming, United States
• Albury Wodonga Regional Cancer Centre — Albury, New South Wales, Australia
• Coffs Harbour Health Campus — Coffs Harbour, New South Wales, Australia
• St George Private Hospital — Kogarah, New South Wales, Australia
• Lismore Base Hospital — Lismore, New South Wales, Australia
• Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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