CancerCodeTM Informed, Molecularly Targeted Therapies in Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. The three month progression free survival (PFS) of patients treated with targeted agents in the second line setting based on the tumor molecular signature as defined by CancerCode will be 40% vs 20% with standard cytotoxic chemotherapy.
SECONDARY OBJECTIVES:
I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results.
IV. Concordance of variants identified when sequencing is performed on samples from the same patient collected at baseline and follow-up time points.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC) - locally advanced, stage IIIB OR stage IV or stage IVM1A (malignant pleural or pericardial effusion or pleural implants) OR recurrence after primary surgery or radiotherapy (refer to 2010 American Joint Committee on Cancer [AJCC] staging, 7th edition [Ed])
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)-1.1 criteria; previous irradiated tumor is acceptable if there is at least a 20% increase in the size of the previously irradiated lesion
- •Patients must be suitable candidates for treatment with standard regimens; this includes having adequate hematologic parameters, liver function and renal function based on labs that are deemed acceptable for treatment by the investigators
- •Previous radiation allowed provided that 2 weeks has passed since radiation and/or the patient has recovered from the side effects
- •Availability of archival diagnostic tissue (paraffin tissue block, cytospin block from a fine needle aspirate, or unstained slides from resected tumor, core biopsy, or fine needle aspirate) is required
- •Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use effective methods of contraception during active treatment and for the duration of the study
排除标准
- •Prior treatment with any investigational or targeted therapies
- •Patients with known activating mutations in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma receptor tyrosine kinase (ALK) or c-ros oncogene 1, receptor tyrosine kinase (ROS-1) (this test [ROS-1] will be done only on select patients and at the discretion of treating physicians) translocation positive; the mutational status of all patients will be determined prior to study entry
- •Prior malignancy within the past 3 years other than complete resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy
- •Prior systemic therapy within 14 days of initiating protocol treatment
- •Symptomatic brain metastasis or asymptomatic brain metastasis that are 1 cm or greater in size; patients with asymptomatic sub-centimeter brain metastasis are eligible
- •Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly limits patients participation
- •Current, recent (within 2 weeks of enrollment of this study), or planned participation in an experimental drug study
- •Unstable angina
- •Pregnant (positive serum pregnancy test) or breast feeding
- •History of any disease that could lead to impaired absorption of drugs
- •Inability to comply with study and/or follow-up procedures
- •Prior allogeneic bone marrow or organ
研究组 & 干预措施
Arm A (standard of care treatment)
Patients receive standard of care treatment based on the discretion of the treating physician.
干预措施: therapeutic procedure (Procedure)
Arm A (standard of care treatment)
Patients receive standard of care treatment based on the discretion of the treating physician.
干预措施: laboratory biomarker analysis (Other)
Arm B (genetic sequencing and targeted therapy)
Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
干预措施: cytology specimen collection procedure (Other)
Arm B (genetic sequencing and targeted therapy)
Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
干预措施: targeted therapy (Drug)
Arm B (genetic sequencing and targeted therapy)
Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression Free Survival
时间窗: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months
A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient "success" will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.
次要结局
- Proportion of Arm B Patients Whose Second Line Therapy is Changed as a Result of Physician Access to CancerCode-50 Results(Up to 2 years)
- Response Rate Defined by RECIST 1.1(Up to 2 years)