None listed
Conditions
Interventions
ELIGIBLE PATIENTS WILL BE RANDOMIZED IN A 1:1 FASHION TO RECEIVE EITHER AFATINIB OR ERLOTINIB.
PATIENTS WILL RECEIVE CONTINUOUS DAILY DOSING OF STUDY DRUG ASSIGNED UNTIL DISEASE PROGRESSION, UNACCE
Sponsors
Boehringer Ingelheim,
Eligibility
Inclusion criteria
Inclusion criteria: 1. DIAGNOSIS OF ADVANCED STAGE NSCLC CONSIDERED TO BE SQUAMOUS HISTOLOGY, INCLUDING MIXED HISTOLOGY, IN THE OPINION OF THE INVESTIGATOR. 2. COMPLETION OF AT LEAST 4 CYCLES OF PLATINUM-BASED DOUBLET CHEMOTHERAPY, WITH OR WITHOUT ADDITIONAL [NON-EGFR] TARGETED AGENTS, AS 1ST LINE TREATMENT OF STAGE IIIB/IV NSCLC. THIS INCLUDES PATIENTS RELAPSING WITHIN 6 MONTHS OF COMPLETING ADJUVANT/NEO-ADVJUVANT/CURATIVE –INTENT CHEMOTHERAPY/CHEMORADIOTHERAPY. (NOTE: THESE PATIENTS ARE STILL REQUIRED TO HAVE HAD THE EQUIVALENT OF 4 CYCLES OF PLATINUMBASED DOUBLET CHEMOTHERAPY) 3. ELIGIBLE TO RECEIVE 2ND LINE THERAPY IN THE OPINION OF THE INVESTIGATOR. PATIENTS WHO RECEIVED NON-EGFR BASED THERAPY FOR MAINTENANCE ARE ELIGIBLE. 4. MEASURABLE DISEASE ACCORDING TO RECIST 1.1 (R09-0262). REFER TO APPENDIX 10.1. 5. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) SCORE OF 0 OR 1 (RO1-0787). REFER TO APPENDIX 10.2. 6. AVAILABILITY OF TUMOUR TISSUE MATERIAL FOR CORRELATIVE STUDIES (REFER TO SECTION 5.6). ARCHIVED TUMOUR TISSUE IS ACCEPTABLE. 7. ADEQUATE ORGAN FUNCTION, DEFINED AS ALL OF THE FOLLOWING: A. L VEF >50% OR WITHIN INSTITUTION NORMAL VALUES.
Exclusion criteria
Exclusion criteria: 1. PRIOR TREATMENT WITH EGFR DIRECTED SMALL MOLECULES OR ANTIBODIES. 2. CURATIVE INTENT CHEMORADIOTHERAPY AS THE ONLY TREATMENT FOR STAGE IIIB NSCLC UNLESS RELAPSE OCCURS WITHIN 6 MONTHS OF COMPLETION OF TREATMENT, AND IN THE OPINION OF THE INVESTIGATOR THE PATIENT HAS RECEIVED AN EQUIVALENT OF 4 CYCLES OF PLATINUM-BASED DOUBLET THERAPY. 3. RADIOTHERAPY WITHIN 4 WEEKS PRIOR TO RANDOMIZATION, EXCEPT AS FOLLOWS: A. PALLIATIVE RADIATION TO TARGET ORGANS OTHER THAN CHEST MAY BE ALLOWED UP TO 2 WEEKS PRIOR TO RANDOMIZATION, AND B. SINGLE DOSE PALLIATIVE TREATMENT FOR SYMPTOMATIC METASTASIS OUTSIDE ABOVE ALLOWANCE TO BE DISCUSSED WITH SPONSOR PRIOR TO ENROLLING. 4. ACTIVE BRAIN METASTASES (STABLE FOR <4 WEEKS, SYMPTOMATIC, OR LEPTOMENINGEAL DISEASE). DEXAMETHASONE THERAPY WILL BE ALLOWED IF ADMINISTERED AS A STABLE DOSE FOR AT LEAST 4 WEEKS BEFORE RANDOMIZATION. 5. ANY OTHER CURRENT MALIGNANCY OR MALIGNANCY DIAGNOSED WITHIN THE PAST THREE (3) YEARS (OTHER THAN BASAL-CELL CARCINOMA OF THE SKIN, IN SITU CERVICAL CANCER, IN SITU PROSTATE CANCER). 6. KNOWN PRE-EXISTING INTERSTITIAL LUNG DISEASE.
Countries
Argentina, Austria, Canada, Chile, China, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea North, Mexico, Netherlands, Portugal, Singapore, Spain, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed