Erlotinib treatment beyond progression in EGFR mutant or patients who have responded to EGFR TKI in stage IIIB/IV NSCLC - ETAP

Oulu University Hospital0 个研究点开始时间: 2013年7月15日最近更新: 2017年5月8日

适应症

试验速览

暂无简介。

•1.Signed informed consent obtained prior to any study specific screening procedures.
•2.Histologically confirmed stage IIIB/IV NSCLC.
•3.Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
•4.Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting > 6 months
•5.Age >18
•6.Performance status: WHO 0-2
•7.Measurable disease according to RECIST 1.1
•8.Patients must be able to comply with study treatments
•9.Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
•10.Neutrophils < 1’000/ul, Platelets < 100’000/ul, Alanine amino transferase < 2.5 x Upper limt of normal (ULN) (< 5 x ULN if liver metastases), Alkaline phosphatase < 2.5 x ULN (< 5 x ULN if liver metastases), Serum bilirubin < 1.5 x ULN, Serum Creatinine < 1.5 x ULN.
•11.Patient must be able to comply with the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.Previous EGFR TKI treatment beyond RECIST 1.1 defined disease progression for more than 28 days
•2.Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment
•3.Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib
•4.Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study
•5.Patient with symptomatic central nervous system metastases
•6.Patient has known active hepatitis B or C, or HIV infection
•7.Pregnant or breastfeeding.
•8.Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

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