None listed
Conditions
Interventions
Nivolumab 10mg/ml sol.inyectable,
Ipilimumab 5mg/ml sol.inyectable,
Via: intravenous
Frecuency, duration, treatment gropu: see design
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 98 Years
Inclusion criteria
Inclusion criteria: ECOG Performance Status of 1. •Patients with histologically confirmed Stage IV or recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer classification squamous or nonsquamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease. •Measurable disease by CT or MRI per RECIST 1.1 criteria.
Exclusion criteria
Exclusion criteria: Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy. •Subjects with known ALK translocations which are sensitive to available targeted inhibitor therapy. •Subjects with untreated CNS metastases are excluded, even if asymptomatic. •Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topicalsteroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea South, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, United States
Contacts
Public ContactMarina Ordoñez
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed