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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.
The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
- •Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
- •Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
- •Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
- •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.
- •Patients must have received prior platinum containing treatment.
- •WHO performance status of 0-1
排除标准
- •Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
- •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 been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
- •Prior treatment with an HSP90 inhibitor
研究组 & 干预措施
AUY922 arm
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly.
干预措施: AUY922 (Drug)
chemotherapy arm
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks.
干预措施: Docetaxel (Drug)
chemotherapy arm
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 16 months
Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Response Rate (ORR)(16 months)
- Overall Survival (OS)(from randomization until death up to death)
- Disease Control Rate (DCR)(baseline, until disease progression up to 24 months)
- Time to Response (TRR)(baseline, until disease progression up to 24 months)
- Duration of Response (DOR)(baseline, until disease progression up to 24 months)
- Rate of Adverse Events (AEs)(baseline, until disease progression up to 24 months)
- Change in Laboratory Paramenters(baseline, until disease progression up to 24 months)
- Time to Progression (TTP)(baseline, until disease progression up to 24 months)