None listed
Conditions
Interventions
SUBJECTS WILL UNDERGO SCREENING EVALUATIONS TO DETERMINE ELIGIBILITY WITHIN 28 DAYS PRIOR TO RANDOMIZATION. SUBJECTS WILL BE ASSIGNED TO ONE OF TWO TREATMENT ARMS (SEE STUDY DESIGN AND DURATION IN FI
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT A) SUBJECTS MUST HAVE SIGNED AND DATED AN IRB/IEC APPROVED WRITTEN INFORMED CONSENT FORM IN ACCORDANCE WITH REGULATORY AND INSTITUTIONAL GUIDELINES. THIS MUST BE OBTAINED BEFORE THE PERFORMANCE OF ANY PROTOCOL RELATED PROCEDURES THAT ARE NOT PART OF NORMAL SUBJECT CARE. B) SUBJECTS MUST BE WILLING AND ABLE TO COMPLY WITH SCHEDULED VISITS, TREATMENT SCHEDULE, LABORATORY TESTS INCLUDING COMPLETION OF PATIENT REPORTED OUTCOMES QUESTIONNAIRES AND OTHER REQUIREMENTS OF THE STUDY. 2) TARGET POPULATION A) SUBJECTS WITH HISTOLOGICALLY OR CYTOLOGICALLY-DOCUMENTED LOCALLY ADVANCED NON-SQUAMOUS CELL NSCLC WHO PRESENT WITH STAGE IIIB/STAGE IV OR RECURRENT DISEASE FOLLOWING RADIATION THERAPY OR SURGICAL RESECTION. B) MEN AND WOMEN 18 YEARS OF AGE C) EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF 1 D) SUBJECTS MUST HAVE MEASURABLE DISEASE BY CT OR MR1- PER RECIST 1.1 CRITERIA; RADIOGRAPHIC TUMOR ASSESSMENT PERFORMED WITHIN 28 DAYS OF RANDOMIZATION
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE EXCEPTIONS A) SUBJECTS WITH CARCINOMATOUS MENINGITIS B) SUBJECTS WITH ACTIVE CNS METASTASES ARE EXCLUDED. SUBJECTS ARE ELIGIBLE IF CNS METASTASES ARE ADEQUATELY TREATED AND SUBJECTS ARE NEUROLOGICALLY RETURNED TO BASELINE (EXCEPT FOR RESIDUAL SIGNS OR SYMPTOMS RELATED TO THE CNS TREATMENT) FOR AT LEAST 2 WEEKS PRIOR TO ENROLLMENT. IN ADDITION, SUBJECTS MUST BE EITHER OFF CORTICOSTEROIDS, OR ON A STABLE OR DECREASING DOSE OF ≤ 10 MG DAILY PREDNISONE (OR EQUIVALENT). 2) MEDICAL HISTORY AND CONCURRENT DISEASES A) ANY SERIOUS OR UNCONTROLLED MEDICAL DISORDER OR ACTIVE INFECTION WITH HEPATITIS OR HIV THAT MAY BE-REACTIVATED B) OTHER ACTIVE MALIGNANCY REQUIRING CONCURRENT INTERVENTION C) SUBJECTS WITH PREVIOUS MALIGNANCIES (EXCEPT NON-MELANOMA SKIN CANCERS, AND THE FOLLOWING IN SITU CANCERS: BLADDER, GASTRIC, COLON, CERVICAL/DYSPLASIA, ENDOMETRIAL, MELANOMA, OR BREAST) ARE EXCLUDED UNLESS A COMPLETE REMISSION WAS ACHIEVED AT LEAST 2 YEARS PRIOR TO STUDY ENTRY AND NO ADDITIONAL THERAPY IS REQUIRED OR ANTICIPATED TO BE REQUIRED DURING THE STUDY PERIOD
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, France, Germany, Italy, Mexico, Singapore, Spain, Switzerland, United States
Contacts
Public ContactMarina Ordoñez
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed