Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
研究概览
简要总结
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
- •Is between the ages of 18 and 75 years old, inclusive
- •Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
- •Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
- •Has an ECOG performance status of 0 or 1
- •Has a life expectancy of > 3 months
- •Has adequate hematologic function as evidenced by:
- •ANC ≥ 1,500/μL
- •PLT ≥ 100,000/μL
- •HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
- •Has adequate renal function as evidenced by:
- •Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- •Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
- •Has adequate hepatic function as evidenced by:
- •Serum total bilirubin ≤ 1.0 mg/dL
- •AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- •ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
- •If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
排除标准
- •Has received prior systemic chemotherapy at any time for lung cancer;
- •Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
- •Has a known hypersensitivity to baker's yeast, or has an active yeast infection
- •Has had previous exposure to Betafectin® or Imprime PGG
- •Has an active infection
- •Presents with any of the following medical diagnoses/conditions at the time of screening:
- •Central nervous system (CNS) metastases
- •Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
- •Peripheral neuropathy ≥ grade 2 from any cause
- •Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
- •Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
- •Has a history of any of the following medical diagnoses/conditions:
- •Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- •Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
- •Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
- •Has a know sensitivity to Cremophor EL
- •Has previously received treatment with cetuximab
- •If female, is pregnant or breast-feeding
- •Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
- •Has previously received an organ or progenitor/stem cell transplant.
研究组 & 干预措施
Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
干预措施: Imprime PGG Injection (Biological)
Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
干预措施: Cetuximab (Biological)
Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
干预措施: Paclitaxel (Drug)
Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
干预措施: Carboplatin (Drug)
Control
Cetuximab + Paclitaxel/Carboplatin
干预措施: Cetuximab (Biological)
Control
Cetuximab + Paclitaxel/Carboplatin
干预措施: Paclitaxel (Drug)
Control
Cetuximab + Paclitaxel/Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
时间窗: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
次要结局
- Overall Survival (OS) in Each Study Arm Based on the Safety Population(From the time of randomization to death, subject being lost to follow-up or study completion)
- Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review(From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months)
- Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review(From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months)
- Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review(From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months)
- Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review(From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months)