None listed
Conditions
Interventions
MALE AND FEMALE PATIENTS AGED ≥
18 YEARS WITH AN EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUSOF 0 OR 1 WHO HAVE FAILED AT LEAST ONE PRIOR LINE OF PLATINUM-BASED TREATMENT BUT HAVE HAD NO MORE THAN TWO PRIOR LINES OF
Sponsors
GENENTECH, INC.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. SIGNED WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY-SPECIFIC SCREENING PROCEDURE. 2. MALE O FEMALE, 18 YEARS OF AGE OR OLDER. 3. PATIENTS WITH ECOG PERFORMANCE STATUS OF 0-1 (SEE APPENDIX C). 4. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED INCURABLE STAGE IIIB/IV NSCLC TUMOR. 5. MET DIAGNOSTIC-POSITIVE STATUS (≥ 50 % OF TUMOR CELLS WITH MEMBRANE AND/OR CYTOPLASMIC STAINING AT MODERATE TO HIGH INTENSITY) AND RESULTS OF EGFR-ACTIVATING MUTATION TESTING, AS DETERMINED BY THE CENTRAL LABORATORY. . TUMOR TISSUE SAMPLE REQUIREMENTS ARE DESCRIBED IN SECTION 4.5.1.G. . A COMPARATION PROTOCOL IS AVALAIBLE UNDER WHICH A PATIENT´S ARCHIVAL TUMOR BLOCK OR SLIDES MAY BE SENT FOR CENTRAL MET AND EGFR TESTING WHILE THE PATIENT IS UNDERGOING INITIAL OR FIRST-LINE THERAPY. 6. RADIOGRAPHIC EVIDENCE OF DISEASE (MEASURABLE DISEASE NOT MANDATORY). . THE LESIONS MUST BE OUTSIDE A PREVIOUS RADIOTHERAPY FIELD IF THEY ARE THE SOLE SITE OF DISEASE, UNLESS DISEASE PROGRESSION HAS BEEN DICUMENTED AT THAT SITE SINCE RADIATION. 7. PRIOR TREATMENT WITH AT LEAST ONE PLATINUM-BASED LINE OF TREATMENT (IN METASTATIC STAGE) AND NO MORE THAN ONE ADDITIONAL LINE OF CHEMOTHERAPY TREATMENT. . MAINTENANCE THERAPY WITH A CYTOTOXIC REGIMEN THAT DIFFERS FORM FIRST-LINE THERAPY IS CINSIDERED AN ADDITIONAL LINE OF THERAPY. HOWEVER A CHANGE OF SYSTEMIC REGIMEN FOR REASONS OF INTOLERANCE OR EXCESSIVE TOXICITY DOES NOT CONSTITUTE AN ADDITIONAL REGIMEN. COMBINED TREATMENT WITH CHEMOTHERAPY AND RADIATION CONSTITUTES A
Exclusion criteria
Exclusion criteria: A.CANCER RELATED . MORE THAN 30 DAYS OF EXPOSURE TO AN INVESTIGATIONAL OR MARKERED AGENT THAT CAN ACT BY EGFR INHIBITION, OR A KNOWN EGFR-RELATED TOXICITY RESULTING IN DOSE MODIFICATIONS. EGFR INHIBITORS INCLUDE (BUT ARE NOT LIMITED TO) GEFITINIB, ERLOTINIB, AND CETUXIMAB. . BRAIN METASTASIS OR SPINAL CORD COMPRESSION NOT DEFINITIVELY TREATED WITH SURGERY AND/OR RADIATION, OR PREVIOUSLY DIAGNOSED AND TREATED CENTRAL NERVOUS SYSTEM (CNS) METASTASES OR SPINAL CORD COMPRESSION WITHOUT EVIDENCE OF STABLE DISEASE (CLINICALLY STABLE IMAGING) FOR ≥ 14 DAYS. NOTE: PATIENTS WITH TREATED CNS METASTASES WHO ARE ASYMPTOMATIC AND ON A STABLE DOSE OF CORTICOSTEROIDS FOR ≥ 14 DAYS PRIOR THE RANDOMIZATION ARE ELEGIBLE. . HISTORY OF ANOTHER MALIGNANCY IN THE PREVIOUS 3 YEARS, UNLESS CURED BY SURGERY ALONE AND CONTINUOUSLY DISEASE FREE FOR AT LEAST 3 YEARS. NOTE: PATIENTS WITH PRIOR HISTORY OF NON-INVASIVE CANCERS ARE ELEGIBLE. . LIFE EXPECTANCY 2.5 X UPPER LIMIT OF NORMAL (ULN). . TOTAL BILIRUBIN >
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea North, Netherlands, Poland, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed