Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation
An Open-label, Multicenter, Phase II Study of Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、138-736
- 招聘中
- Asan Medical Center
-
接触:
- Sang-We Kim, M.D.
- 电话号码:82-2-3010-3215
- 邮箱:swkim@amc.seoul.kr
-
首席研究员:
- Sang-We Kim, M.D.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects with histologically or cytologically confirmed, unresectable stage IIIB/IV NSCLC that carries a V600 BRAF mutation, as per NGS ECOG performance status of 0 to 2 Male or female; ≥ 18 Subjects with measurable lesion (using RECIST 1.1 criteria) Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since Patients who have progressed during or after 1st line or 2nd line therapy prior to the first dose of dabrafenib/trametinib. For patient who have received prior platinum containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease, those treatments are regarded as 1st line if the progression has occurred < 12 months from last therapy.
Subjects who meet the following criteria:
Absolute neutrophil count (ANC) >1.5 x 109/L Platelet count >100 x 109/L Serum creatinine >1.5 x upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) > 3 x upper limit of normal (ULN) (If there is Liver Metastasis > 5 x upper limit of normal (ULN)) Total bilirubin>1.5 x upper limit of normal (ULN) the progression has occurred < 12 months from last therapy. Patients with asymptomatic brain metastasis could be eligible. Provision of written informed consent prior to any study specific procedures
Exclusion Criteria:
Any major operation or irradiation within 4 weeks of baseline disease assessment Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms Subjects with chemotherapy naïve or those who already had received two lines of chemotherapy including immunotherapy or targeted therapy.
Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ.
Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension) Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of drug pneumonitis, hypersensitivity pneumonitis, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention).
Pregnant or lactating female Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with IPs for the duration of participation:
Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (please refer to http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) Strong inhibitors or strong inducers of CYP2C8 and CYP3A4 Unstable or increasing doses of corticosteroids enzyme-inducing anticonvulsive agents herbal supplements Patients who have received thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment is allowed
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective response rate
大体时间:At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1
|
At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
反应持续时间
大体时间:在第 6 周,然后每 6 周一次,直到第 36 周。然后每 12 周一次,直到出院,平均 13.8 个月
|
DOR 计算为从第一份完全缓解 (CR) 或部分缓解 (PR) 记录的日期到第一份记录的进展前疾病 (PD) 或因任何原因导致 PR 或 CR 患者死亡的时间。
|
在第 6 周,然后每 6 周一次,直到第 36 周。然后每 12 周一次,直到出院,平均 13.8 个月
|
总生存期
大体时间:在第 6 周,然后每 6 周一次,直到第 36 周。然后每 12 周一次,直到出院,平均 13.8 个月
|
在第 6 周,然后每 6 周一次,直到第 36 周。然后每 12 周一次,直到出院,平均 13.8 个月
|
|
Progression-free survival
大体时间:At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
. PFS is defined as time from the first dose of investigational products (IPs) to progression or death due to any cause.
OS is defined as time from the first dose of IPs to death due to any cause.
|
At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
Disease control rate
大体时间:At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
DCR is calculated as the proportion of patients with best response of CR, PR and SD.
|
At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
daborafenib plus trametinib的临床试验
-
InBios International, Inc.Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC完全的
-
Azienda Sanitaria Locale Napoli 2 Nord招聘中
-
Zona Health, IncResearch & Development Concierge Company终止
-
Fondazione Policlinico Universitario Agostino Gemelli...尚未招聘尿路感染 | 输尿管支架相关症状
-
Yonsei University尚未招聘