EUCTR2012-002447-14-HU进行中（未招募）1 期
A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer - ENSPIRIT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
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.Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition of tumor, nodes and metastases classification of malignant tumors [TNM] staging) NSCLC
- •2.Males or females = 18 years of age at screening.
- •3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
- •4.Patients must have received one prior line of platinum-based systemic anticancer therapy for advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued at the end of a treatment regimen. (Note: prior platinum-based therapy in the neoadjuvant or adjuvant setting for early-stage disease is allowed.)
- •5.Patients must have documented radiological disease progression either during or after the first-line therapy.
- •6.Patients must have at least one measurable lesion per RECIST 1.1 criteria.
- •7.ECOG PS of 0 or 1 at screening.
- •8.Have adequate bone marrow, renal and liver functions at screening as defined below:
- •-Absolute neutrophil count (ANC) = 1.5 x 109/L
- •-Platelet count = 100 x 109/L
- •-Hemoglobin = 9 g/dL
- •-Serum creatinine = 1.5 x upper limit of normal (ULN)
- •-Total Bilirubin=1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert’s disease)
- •-Aspartate transaminase (AST) and alanine transaminase (ALT)=1.5 x ULN
- •9.Resolution of any toxic effects of prior therapy to Grade =1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and = Grade 2 peripheral neuropathy).
- •10.Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
- •11.Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
- •12.Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 420
排除标准
- •1.Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab).
- •2.Radiotherapy = 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
- •3.Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
- •4.Patients with known central nervous system (CNS) metastases (Patients with any clinical signs of CNS metastases must have a CT or MRI of the brain to rule out CNS metastases in order to be eligible for participation in the study. Patients who have had brain metastases treated with radiotherapy or surgically removed with no residual disease confirmed by imaging should be clinically stable and off corticosteroid treatment at least 3 weeks prior to randomization).
- •5.Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
- •6.Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (= Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
- •7.A history of events such as myocardial infarction, cerebrovascular accident (CVA) or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
- •8.Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
- •9.Female patients who are breastfeeding.
- •10.Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies. (Note: Prior use of paclitaxel is allowed.)
- •11.Patients with known and documented EGFR mutation who have not received an EGFR inhibitor.
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