Avelumab in First-line NSCLC (JAVELIN Lung 100) | NCT02576574 | Trialant

Avelumab in First-line NSCLC (JAVELIN Lung 100) | NCT02576574 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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