SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Merrimack Pharmaceuticals Inc.)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.
详细描述
This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent
- •Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease
- •Tissue submitted for HRG-biomarker testing
- •ECOG performance status (PS) of 0 or 1
排除标准
- •Known ALK mutation
- •Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
- •Received >2 prior systemic anti-cancer drug regimen for locally advanced disease
- •Prior treatment with an anti-ErbB3 antibody
- •CTCAE grade 3 or higher peripheral neuropathy
- •Symptomatic CNS metastases or CNS metastases requiring steroids
- •Any other active malignancy requiring systemic therapy
- •Clinically significant cardiac disease
研究组 & 干预措施
Arm A: Experimental Arm
MM-121 in combination with Docetaxel
干预措施: MM-121 (Drug)
Arm A: Experimental Arm
MM-121 in combination with Docetaxel
干预措施: Docetaxel (Drug)
Arm B: Comparator Arm
Docetaxel alone
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
次要结局
- Time to Progression(Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely))
- Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone(TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months)
- Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.(The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment through concentrations of MM-121)
- Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone(TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months)
- Overall Survival(From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely))
- Objective Response Rate(Randomization through end of study up to 3 years, 11 months (the study terminated prematurely))