EUCTR2014-003084-37-CZ进行中（未招募）1 期
A phase I/II study to evaluate safety and efficacy of DCVAC/LuCa added to standard first line chemotherapy with carboplatin and paclitaxel +/- immune enhancers (interferon-a and hydroxychloroquine) vs chemotherapy alone in patients with Stage IV non-small cell lung cancer
SOTIO a.s.0 个研究点目标入组 98 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 Histologically or cytologically confirmed non-small cell lung cancer
- •(NSCLC) of either adenomatous, squamous or large cell carcinoma
- •differentiation; mixed tumors will be categorized by the predominant cell
- •2 Advanced NSCLC (stage IV unresectable disease)
- •3 Patients must have measurable or non-measurable disease
- •4 Patients (male and female) = 18 years
- •5 Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- •6 Patients must have recovered from toxicity of any prior therapy (e.g. surgery, radiotherapy, or therapy for other diseases than NSCLC). Recovery is defined as less than or equal to grade 2 toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (except alopecia
- •7 Laboratory criteria
- •7.1 Platelet count of at least 100,000/mm3 (100 x 109/L)
- •7.2 White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
- •7.3 Hemoglobin (Hb) at least 9g/dL (90 g/L)
- •7.4 Total bilirubin levels =1.5mg/dL (benign hereditary hyperbilirubinemias,
- •e.g., Gilbert´s syndrome are permitted)
- •7.5 Serum alanine aminotransferase and aspartate aminotransferase = 5
- •times the upper limit of normal (ULN)
- •7.6 Serum creatinine = 1.5 times the upper limit of normal (ULN)
- •8 Women of childbearing potential and sexually active males must agree to
- •use an accepted and effective method of contraception (hormonal or barrier
- •methods, abstinence) prior to study entry and for the duration of the
- •treatment plus 3 months.
- •9 Signed informed consent including patient’s ability to comprehend its
- •contents. (Consent to genetic testing is not a condition for participation in
- •the clinical trial)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •1 Prior chemotherapy for stage IV NSCLC
- •2 Immunotherapy, monoclonal antibodies received within 4 weeks prior to
- •randomization
- •3 Patients comorbidities
- •3.1 Patients who are not indicated for chemotherapy treatment with first
- •line Standard of Care chemotherapy (carboplatin/paclitaxel)
- •3.2 Active other malignancy than NSCLC
- •3.3 Known central nervous system (CNS) metastases
- •3.4 Any disease requiring chronic steroid or immunosuppressive therapy
- •3.5 HIV positive
- •3.6 Active hepatitis B (HBV) and/or C (HCV), active syphilis
- •3.7 Ongoing/active significant infection or other severe medical
- •3.8 Pre-existing thyroid disease unless it can be controlled with
- •conventional treatment
- •3.9 Clinically significant cardiovascular disease including:
- •3.9.1 Uncontrolled congestive heart failure
- •3.9.2 Unstable angina pectoris
- •3.9.3 Uncontrolled severe cardiac arrhythmia
- •3.9.4 Myocardial infarction within 6 months prior
- •randomization
- •3.10 Psychiatric illness/social situations that would limit compliance with
- •study requirements
- •4 Pregnant or breast feeding women
- •5 Use of any experimental therapy within 4 weeks prior to randomization
- •6 Contra indications to treatment with hydroxychloroquine, known G6PD
- •deficiency (anamnestic information, no test necessary) and psoriasis
研究者
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