EUCTR2011-005968-24-GR进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III) - VaxLung
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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.Male or female >/=18 years of age;
- •2.Documented stage IV NSCLC as defined by IASLC Lung Cancer Staging Project (7th edition) or recurrent stage I-III disease at least 6 months after resection or after the end of adjuvant chemotherapy or after standard locoregional treatment as defined by the American College of Chest Physicians;
- •3.Patients treated with 4 cycles platinum based 1st line chemotherapy as defined by the American College of Chest Physicians (i.e. radiotherapy are not allowed except palliative radiotherapy of bone metastasis);
- •4.Documented HLA-A*0201 positivity, as determined by a local laboratory;
- •5.TERT-positive NSCLC, as assessed by a central laboratory; for this, availability of adequate tissue biopsy from the primary tumor, lymph nodes or distant metastases is a prerequisite;
- •6.CR, PR, or SD according to RECIST criteria after the completion of platinum-based first-line chemotherapy;
- •7.First vaccination have to be administered no more than 4 weeks after the last administration of platinum-based 1st line chemotherapy;
- •8.ECOG performance status 0, 1;
- •9.Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
- •10.Patients must have adequate haematological function:
- •Platelet count >/= 100 x 109/L;
- •WBC count >/= 2.5 x 109/L;
- •Hemoglobin >/= 90g /L;
- •11.Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential must have a negative urine pregnancy test at baseline and agree to practice adequate contraception for 30 days prior to administration of investigational product, throughout the study treatment period and 30 days after completion of injections;
- •12.In the investigator’s opinion, the patient is capable and willing to comply with the requirements of the study;
- •13.Willing and able to sign a written informed consent.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1.Mixed small cell and NSCLC histologies;
- •2.Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy;
- •3.Prior treatment with cancer vaccines;
- •4.Prior treatment with immunotherapy (eg interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
- •5.Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
- •6.Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
- •7.Patients with symptomatic brain metastases;
- •8.Past and current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated with no evidence of disease for at least five years;
- •9.Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
- •10.Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for COPD or topical steroids is allowed;
- •11.Known hepatitis B and/or C infection, testing not required;
- •12.Known HIV-positivity, testing not required;
- •13.Clinically significant hepatic dysfunction (ALT>2.5 times normal upper limits [ULN], AST>2.5 times ULN, bilirubin>1.5 times ULN);
- •14.Clinically significant renal dysfunction (serum creatinine>1.5 time ULN);
- •15.Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of randomization) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable);
- •16.Splenectomy or splenic irradiation;
- •17.Any infectious condition that, in the opinion of the investigator, could compromise the patient’s ability to develop an immune response;
- •18.Pregnant or lactating females (female patients of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
- •19.Alcohol or drug use or dependence;
- •20.Requirement of concurrent treatment with prohibited medication (investigational product, other anti-cancer treatments including chemotherapy, non-palliative radiotherapy, biological agents and immunomodulating agents, systemic immunosuppressive agents, including systemic corticosteroids);
- •21.The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
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