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ClinicalTrials.gov Identifier: NCT01861223
Recruitment Status : Unknown
Verified February 2014 by Myung-Ju Ahn, Samsung Medical Center. Recruitment status was: Recruiting
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically confirmed diagnosis of stage IIIB or IV NSCLC
Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
Disease progression on treatemtn with gefitinib or erlotinib within 30 days
Biopsy on disease progression
Age ≥20 years
ECOG performance status of 0, 1, or 2
Measurable disease by the criteria of RECIST 1.1
Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 45 mL/min
Known interstitial lung disease
Prior treatment with EGFR targeting antibodies or BIBW 2992
Prior three or more lines of chemotherapy for advanced NSCLC
Significant bowel disease impairing drug absorption
Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.