A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
- •Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort
- •Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- •The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
- •Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)
- •The participant has archived tumor tissue available for biomarker analyses.
- •Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.
排除标准
- •The participant has nonsquamous NSCLC
- •The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
- •The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).
- •The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
- •The participant has a bleeding tumor.
- •The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.
- •The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.
- •The participant has experienced myocardial infarction within 6 months prior to study enrollment.
研究组 & 干预措施
Cohort 2: Necitumumab + Gemcitabine and Carboplatin
Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
干预措施: Gemcitabine (Drug)
Cohort 1: Necitumumab + Gemcitabine and Carboplatin
Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
干预措施: Necitumumab (Drug)
Cohort 1: Necitumumab + Gemcitabine and Carboplatin
Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
干预措施: Gemcitabine (Drug)
Cohort 1: Necitumumab + Gemcitabine and Carboplatin
Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
干预措施: Carboplatin (Drug)
Cohort 2: Necitumumab + Gemcitabine and Carboplatin
Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
干预措施: Necitumumab (Drug)
Cohort 2: Necitumumab + Gemcitabine and Carboplatin
Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
时间窗: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months)
次要结局
- Overall Survival (OS)(Baseline to Date of Death Due to Any Cause (Approximately 24 Months))
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab(Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months))
- Progression Free Survival (PFS)(Baseline to Measured Progressive Disease or Death (Approximately 24 Months))
- Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease(Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months))