A Phase II Trial of Sunitinib in Never-smokers With Lung Adenocarcinoma: Identification of Oncogenic Alterations Underlying Sunitinib Sensitivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved sunitinib for your type of cancer.
Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking certain protein signals within the cell. Because sunitinib works differently from standard intravenous chemotherapies, we call it a "targeted therapy." This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors.
In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been found to be more sensitive to other kinds of oral targeted therapies. This study will focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.
详细描述
Primary Objectives
- To evaluate the objective response rate (ORR) to sunitinib in never-smokers with lung cancers that are wild-type for EGFR, KRAS, and ALK in a single-arm phase II trial
Secondary Objectives
- To identify oncogenic alterations underlying sensitivity to sunitinib through performing nextgeneration sequencing (NGS) of lung cancers treated with sunitinib
- To explore the activity of sunitinib in lung cancers known to harbor a RET rearrangements and other genomic alterations in targets of sunitinib (e.g. cKIT, PDGFRa, PDGFRb).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer
- •Adenocarcinoma histology of any variant, including adenosquamous histology
- •Wild-type for mutations in EGFR, KRAS and ALK
- •Must have < 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol
- •Disease must be measureable per RECIST 1.1
- •At least one prior systemic therapy (adjuvant or palliative)
- •18 years or older
- •Life expectancy of greater than 4 weeks
- •Adequate ECOG performance status 0 or 1
- •Adequate organ function as defined in the protocol
- •Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue
排除标准
- •Pregnant or breastfeeding
- •Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier
- •Radiation therapy within 2 weeks prior to entering study
- •Major surgery within 4 weeks prior to entering the study
- •Receiving any other investigational agents
- •Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
- •Use of certain inhibitors and inducers of CYP3A4
- •Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry
- •History of significant bleeding disorder unrelated to cancer
- •Poorly controlled hypertension
- •Severe cardiovascular disease
- •Prolongation of corrected QT interval
- •History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer
- •HIV positive on combination antiretroviral therapy
研究组 & 干预措施
Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
干预措施: Sunitinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).
Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.
次要结局
未报告次要终点
研究者
Geoffrey Oxnard, MD
Prinicipal Investigator
Dana-Farber Cancer Institute