A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 33
- 主要终点
- Objective Response Rate as Per Investigator
研究概览
简要总结
The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.
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
- •Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
- •Measurable target disease assessed by the investigator according to RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
排除标准
- •NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
- •Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
- •Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed > 12 months before treatment.
- •Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented > 6 months before starting study treatment.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
MORAb-202
干预措施: MORAb-202 (Drug)
结局指标
主要结局
Objective Response Rate as Per Investigator
时间窗: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Number of Participants With Drug -Related Adverse Events Leading to Discontinuation
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
次要结局
- Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)(From first dose and 30 days after last dose of study therapy (up to approximately 12 months).)
- Disease Control Rate as Per Investigator(From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months))
- Duration of Response as Per Investigator(From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months))
- Progression Free-Survival as Per Investigator(From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months))