A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment

ovartis Pharma Services AG0 个研究点目标入组 108 人开始时间: 2012年9月11日最近更新: 2015年12月7日

适应症

试验速览

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•1. patients with histologically or cytologically documented, locally advanced (stage IIIB who are amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
•2. Patients that have EGFR gene mutation in their tumors
•3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
•4. Patients must have received platinum based prior treatment.
•5. WHO performance status of 0-1
•Other protocol-defined inclusion criteria may apply
•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 84
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease.
•2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: patients who have been treated for CNS metastases by radiation or gamma knife surgery, who have been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
•3. Prior treatment with an HSP90 inhibitor.
•Other protocol-defined exclusion criteria may apply

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