Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
研究概览
简要总结
The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgically resectable Stage I and II non-small cell lung cancer
- •Able to give informed consent
- •Age ≥ 18 and ≤ 80 years old
- •Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon
- •No prior history of malignancy
- •No neoadjuvant therapy
- •Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
- •Hemoglobin (hgb) ≥ 90 g/L
- •White blood cell count (WBC) > 3 x 109/L
- •Platelet count (plt) ≥ 100 x 109/L
- •Serum creatinine ≤ 1.5 times upper reference range
排除标准
- •Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug
- •Pregnant or nursing
- •Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products
- •Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- •Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
研究组 & 干预措施
Low dose intermediate time
Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
干预措施: IRDye800CW-nimotuzumab (Drug)
High dose intermediate time
Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
干预措施: IRDye800CW-nimotuzumab (Drug)
Optimal dose early time
Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
干预措施: IRDye800CW-nimotuzumab (Drug)
Optimal dose late time
Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
干预措施: IRDye800CW-nimotuzumab (Drug)
结局指标
主要结局
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
时间窗: up to 14 days
To identify the dose with the highest tumor fluorescence and TBR.
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
时间窗: up to 14 days
To identify the imaging time with the highest tumor fluorescence and TBR.
次要结局
- Determine primary tumor margins.(up to 14 days)
- Identify EGFR positive lymph nodes.(up to 14 days)
- Safety of IRDye800CW-nimotuzumab(up to 14 days)
研究者
Steven Bharadwaj
Thoracic surgeon
University of Saskatchewan