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 IN A 1:1 RATIO (SEE STUDY DESIGN AND
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT 1. 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. 2. 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 1. MEN AND WOMEN 18 YEARS OF AGE 2. SUBJECTS WITH HISTOLOGICALLY- OR CYTOLOGICALLY-DOCUMENTED SQUAMOUS CELL NSCLC WHO PRESENT WITH STAGE IIIB/ STAGE IV DISEASE (ACCORDING TO VERSION 7 OF THE INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG CANCER STAGING MANUAL IN THORACIC ONCOLOGY), OR RECURRENT DISEASE FOLLOWING RADIATION THERAPY OR SURGICAL RESECTION. 3. SUBJECTS MUST HAVE EXPERIENCED DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER ONE PRIOR PLATINUM-CONTAINING DOUBLET CHEMOTHERAPY REGIMEN FOR ADVANCED OR METASTATIC DISEASE. A. SUBJECTS WHO RECEIVED ERLOTINIB AS MAINTENANCE THERAPY (NON-PROGRESSORS WITH PLATINUM-BASED DOUBLET CHEMOTHERAPY) AND PROGRESSED ARE ELIGIBLE. HOWEVER, SUBJECTS WHO RECEIVED A TYROSINE KINASE INHIBITOR AFTER FAILURE OF A PRIOR PLATINUM-BASED THERAPY ARE EXCLUDED.
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE EXCEPTIONS 1. 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 EQUIVALENT) OR OTHER IMMUNOSUPPRESSIVE MEDICATIONS WITHIN 14 DAYS OF RANDOMIZATION. INHALED OR TOPICAL STEROIDS, AND ADRENAL REPLACEMENT STEROID DOSES > 10 MG DAILY PREDNISONE EQUIVALENT, ARE PERMITTED IN THE ABSENCE OF ACTIVE AUTOIMMUNE DISEASE.
Countries
Argentina, Australia, Austria, Chile, Czech Republic, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, United Kindgdom, United States
Contacts
Public ContactNancy Chacon
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed