None listed
Conditions
Interventions
SUBJECTS WILL BE RANDOMIZED IN A 1:1 RATIO TO ARQ 197 AT 360 MG TWICE DAILY (TOTAL DAILY DOSE, 720 MG.) + ERLOTINIB ONCE DAILY, OR PLACEBO TWICE DAILY + ERLOTINIB 150 MG ONCE DAILY, TO BE ADMINISTERED
Sponsors
DAIICHI SANKYO PHARMA DEVELOPMENT,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MALE OR FEMALE AT LEAST 18 YEARS OF AGE. 2. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED SURGICALLY UNRESECTABLE LOCALLY ADVANCED OR METASTASIC (STAGE IIIB/IV) NON-SQUAMOS NSCLC. 3. MEASURABLE DISEASE AND DOCUMENTED DISEASE PROGRESSION FOLLOWING LAST PRIOR THERAPY ACCORDING TO RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) CRITERIA, VERSION 1.1. 4. HAVE RECEIVED ONE OR TWO PRIOR LINES OF SYSTEMIC ANTI-CANCER THERAPY THERAPY FOR ADVANCED OR METASTATIC DISEASE, ONE OF WHICH MUST A PLATINUM-DOUBLET THERAPY. PATIENTS WHO RECEIVED ONLY ADJUVANT TREATMENT WILL BE ELIGIBLE ONLY IF DISEASE PROGRESSION OCCURRED <6 MONTHS AFTER COMPLETION OF ADJUVANT THERAPY. PRIOR MAINTENANCE THERAPY IS ALLOWED AND WILL BE CONSIDERED AS THE SAME LINE OF THERAPY WHEN CONTINUED WITHOUT DISCONTINUATION AFTER INITIATION OF A TREATMENT REGIMEN. 5. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF 0 OR 1. 6. RESOLUTION OF ANY TOXIC EFFECTS OF PRIOR THERAPY (INCLUDING RADIOTHERAPY) ACCORDING TO NCI CTCAE, VERSION 4.0, GRADE ≤ 1 (WITH THE EXCEPTION OF ALOPECIA). SUBJECT MUST HAVE RECOVERED FROM SIGNIFICANT SURGERY-RELATED COMPLICATIONS.
Exclusion criteria
Exclusion criteria: 1. PRIOR THERAPY WITH AN EGFR INHIBITOR AND/OR ARQ 197 (OR OTHER KNOWN c-MET INHIBITOR). 2. RECEIPT OF ANY SYSTEMIC ANTI-TUMOR TREATMENT FOR NSCLC WITHIN 4 WEEKS PRIOR TO RANDOMIZATION. 3. RECEIPT OF PALLIATIVE RADIOTHERAPY WITHIN 2 WEEKS OR RADIOTHERAPY FOR CURATIVE INTENT OF TARGET LESIONS WITHIN 4 WEEKS PRIOR TO RANDOMIZATION. (LESIONS SUBJECTED TO RADIOTHERAPY WITHIN 4 WEEKS PRIOR RANDOMIZATION MAY NOT BE USED AS TARGET LESIONS.) 4. MAJOR SURGICAL PROCEDURE WITHIN 4 WEEKS PRIOR TO RANDOMIZATION. 5. HISTORY OF CARDIAC DISEASE: CONGESTIVE HEART FAILURE DEFINED AS CLASS II TO IV PER NEW YORK HEARTH ASSOCIATION CLASSIFICATION; ACTIVE CORONARY ARTERY DISEASE; PREVIOUSLY DIAGNOSED SYMPTOMATIC BRADYCARDIA (SUBJECTS WITH ASYMPTOMATIC BRADYCARDIA AND HEART RATE ABOVE 50 BPM ARE FOLLOWED), OR OTHER CARDIAC ARRHYTHMIA DEFINED AS ≥ GRADE 2 ACCORDING TO NCI CTCAE, VERSION 4.0 OR UNCONTROLLED HYPERTENSION; MYOCARDIAL INFARCTION THAT OCCURRED WITHIN 6 MONTHS PRIOR TO STUDY ENTRY (MYOCARDIAL INFARCTION THAT OCCURRED > 6 MONTHS PRIOR TO STUDY ENTRY IS PERMITED). 6. CLINICALLY UNSTABLE CNS METASTASIS (TO BE ENROLLED IN THE STUDY, SUBJECTS MUST HAVE CONFIRMATION OF STABLE DISEASE BY MRI OR COMPUTED TOMOGRAPHY (CT) SCAN WITHIN 4 WEEKS OF RANDOMIZATION AND HAVE CNS METASTASES WELL CONTROLLED BY STEROIDS, ANTI-EPILEPTICS OR OTHER SYMPTOM-RELIEVING MEDICATIONS).
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactRosa Adela Chamorro
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed