A randomized phase III study of erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed as first-line therapy for advanced EGFR mutated non-small-cell lung cancer. The NVALT17 study - NVALT17

Stichting NVALT Studies0 个研究点目标入组 150 人开始时间: 2014年7月16日最近更新: 2016年8月16日

适应症

试验速览

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•1.Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and stage IV disease.
•2.At least 10 slides of tumor tissue, as determined by local pathologist, available for additional research questions
•3.Tumor treatment-naive NSCLC patients.
•4.Documented activating EGFR mutation in exon 18, 19 or exon 21.
•5.At least one unidimensionally measurable lesion meeting RECIST1.1 criteria.
•6.ECOG PS 0-3
•7.Age > 18 years
•8.Adequate organ function, including:
•a.Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
•b.Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 3.0 x ULN
•AP, ALT, and AST <5 xULN is acceptable if the liver has tumor involvement
•c.Renal: calculated creatinin clearance > 40 ml/min based on the Cockroft-Gault formula.
•9.Signed informed consent
•10.Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
•11.Estimated life expectancy >12 weeks
•12.Patient compliance.
•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 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•1.Pregnant or lactating women
•2.Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection.
•3.Documented symptomatic brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
•4.Concomitant treatment with any other experimental drug under investigation.
•5.Concomitant treatment with potent CYP3A4 inhibitor, such as ketoconazole, itraconazole, voriconazole, or protease inhibitors, erythromycin or clarithromycin or CYP3A4 inducers such as phenytoin, carbamazepine, barbiturates or St. Johns Wort.
•6.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
•7.Previous cytotoxic chemotherapy for lung cancer less than 2 years before study entry.
•8.For curatively treated lung cancer: (adjuvant) chemotherapy or chemo-radiotherapy less than 12 month prior to the study entry.
•9.Previous or active concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 2 years prior to study entry.
•10.History of HIV infection or chronic hepatitis B or C
•11.Active clinically serious infection
•12.Severe co-morbidity.

发起方

Stichting NVALT Studies