A phase Ib/II, multicenter, open-label study of EGF816 in combination with INC280 in adult patients with EGFR mutated non-small cell lung cancer

ovartis Farmacéutica, S.A.0 个研究点目标入组 78 人开始时间: 2014年10月3日最近更新: 2021年3月22日

适应症

试验速览

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•?Patients (male or female) ? 18 years of age.
•? Patients with histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer.
•? Patients must have EGFR mutation L858R and/or ex19del.
•? Presence of at least one measurable lesion according to RECIST v.1.1
•? ECOG performance status ?2
•? Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g. erlotinib, gefitinib or afatinib, other EGFR TKIs may be allowed after discussion with Novartis).
•? Phase II Group 1 only: Patients with acquired resistance to EGFR TKI treatment defined as documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI therapy (e.g. erlotinib, gefitinib or afatinib, other EGFR TKIs may be allowed after discussion with Novartis) who subsequently demonstrated progression according to RECIST v1.1.
•? Phase II Group 2 only: Advanced NSCLC patients who have not been previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation
•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 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 23

•? Phase Ib and Phase II Group 1 only: Patients who have received more than one prior line of EGFR TKI therapy
•? Phase Ib and Phase II Group 1 only: Patients who have received more than three prior lines of antineoplastic therapy (including EGFR TKI) in the advanced setting.
•? Phase II Group 2 only: Patients who have received more than two previous lines of antineoplastic therapies in advance setting.
•? Phase II Group 2 only: Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors.
•? Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
•? Patients with brain metastases.
•? Patients have out of range laboratory values defined as
•? Absolute Neutrophil Count (ANC) <1.5 x 109/L
•? Hemoglobin (Hb) <9 g/dL
•? Platelets (PLT) <100 x 109/L
•? Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert?s syndrome total bilirubin >2.5 x ULN.
•? AST and/or ALT >3 x ULN
•? Patients with tumor involvement of the liver must have AST and/or ALT >5 x ULN
•? Serum creatinine >1.5 x ULN
•? Measured or calculated creatinine clearance ?45mL/min
•? Asymptomatic serum amylase and lipase > Grade 2
•? Serum amylase or serum lipase CTCAE grade ? 1 with signs and/or symptoms suggesting pancreatitis or pancreatic injury

发起方

ovartis Farmacéutica, S.A.