A Phase II, Multi-center, Single Arm, Open Label Study to Assess Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall Response Rate (ORR) by investigator assessment
研究概览
简要总结
This is an open-label, multicenter, non-randomized, single arm, phase II study to assess efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.
Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination therapy. Patients may continue study treatment until disease progression, unacceptable adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the study. Patients who have met the criteria for disease progression (PD) according to RECIST v1.1 may continue to receive study treatment if the investigator believes the patient is receiving clinical benefit and the patient is willing to continue on study treatment. After discontinuation of study treatment, all patients will be followed for survival until death, lost to follow-up, withdrawal of consent, or end of study.
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 diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition)
- •Presence of a BRAF V600E mutation in lung cancer tissue. BRAF V600E mutation tested by local laboratory (e.g. study center laboratory, local laboratory company) with proper quality control and license to operation by local health authority is allowed.
- •Measurable disease according to RECIST v1.1.
排除标准
- •Previous treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, encorafenib, and XL281/BMS-908662) or MEK inhibitor (including but not limited to trametinib, cobimetinib, binimetinib, AZD6244, and RDEA119) prior to start of study treatment
- •Patients with brain metastases are excluded if their brain metastases are:
- •Symptomatic OR
- •Treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy (as assessed by contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]), OR
- •Asymptomatic and untreated but >1 cm in the longest dimension
- •History of malignancy with confirmed activating RAS mutation at any time.
- •History of interstitial lung disease or pneumonitis
- •A history or current evidence of retinal vein occlusion (RVO)
- •Current evidence of unstable aneurysm or one that needs treatment
- •Other protocol-defined inclusion/exclusion may apply.
研究组 & 干预措施
Dabrafenib +Trametinib
Oral Dabrafenib plus Oral Trametinib
干预措施: Dabrafenib (Drug)
Dabrafenib +Trametinib
Oral Dabrafenib plus Oral Trametinib
干预措施: Trametinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) by investigator assessment
时间窗: Approximately 2 years
ORR, defined as the percentage of patients with a confirmed CR or PR by investigator assessment as per RECIST v1.1 criteria
次要结局
- Disease control rate (DCR)(Approximately 2 years)
- Overall survival (OS)(Approximately 2 years)
- Duration of response (DOR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)