None listed
Conditions
Interventions
Avelumab will be administered as a 1-hour IV infusion at 10 mg/kg once every 2-week treatment cycle. In order to mitigate infusion-related reactions, subjects will receive pretreatment with histamine
Sponsors
Merck KGaA,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before any trial related procedure is undertaken that is not part of the standard patient management 2. Male or female subjects aged ≥ 18 years 3. Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment 4. Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory 5. Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression 6. Subjects must have progressed after an acceptable therapy defined as follows: a. Subjects must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR b. Subjects must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
Exclusion criteria
Exclusion criteria: 1. In the United States only, subjects with a squamous cell histology will be excluded 2. Systemic anticancer therapy administered after disease progression during or following a platinum based combination, with the following exception: Subjects whose disease harbors an activating EGFR mutation who received an EGFR inhibitor AFTER a minimum of 2 cycles of first-line platinum-based therapy. Subjects who tested undetermined or wild-type for EGFR but were previously treated with a TKI are not eligible unless retested and confirmed to be activating EGFR mutation positive 3. Subjects with non-squamous cell NSCLC whose disease harbors an anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown ALK status will require testing for ALK rearrangement (local laboratory, or central laboratory if local testing is not available) and must be determined to be ALK wild-type to be eligible for this trial
Countries
Argentina, Australia, Austria, Brazil, Chile, Colombia, Croatia, Germany, Hungary, Japan, Korea South, Mexico, New Zealand, Poland, Spain, Taiwan, United States
Contacts
Public ContactElvira Mogrovejo
IQVIA RDS Peru S.R.L
Outcome results
None listed