Lung Cancer Clinical Trial

Avelumab in First-line NSCLC (JAVELIN Lung 100)

Summary

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1224

Study ID:

NCT02576574

Recruitment Status:

Active, not recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1224

Study ID:

NCT02576574

Recruitment Status:

Active, not recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

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