A Phase Ib, Open-label, Dose Escalation Trial Investigating Different Doses and Schedules of Sym004 in Combination With Platinum-doublets in Subjects With Stage IV Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Subjects With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC).
The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
- •Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- •Eligibility for platinum-based chemotherapy
- •Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- •Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- •Other protocol defined inclusion criteria could apply
排除标准
- •Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
- •Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
- •In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the treatment of NSCLC, subjects need to have been screened for ALK fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (TKI) therapy
- •In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need to have been screened for EGFR mutations and excluded if positive, unless previously treated and progressed on an appropriate TKI therapy
- •Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
- •Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
- •History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
- •Other protocol defined exclusion criteria could apply
结局指标
主要结局
Number of Subjects With Dose Limiting Toxicities (DLTs)
时间窗: Day 1 to Day 21 of Cycle 1
DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not \>5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not \>5 days; fatigue/headache lasting \< 7 days; nausea/vomiting/diarrhoea lasting not \>3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis \>= Grade 3 lasting \< 7 days; Grade 3 hyperglycemia that resolves in \< 7 days; any laboratory values \>Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision.
次要结局
- Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death(Day 1 up to 28 days after last dose of study drug (up to 53 weeks))