EUCTR2011-000850-48-ES进行中（未招募）1 期
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)Revised Protocol 01 incorporating administrative letter 04 and protocol amendment 04 (dated 09-Feb-2012)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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) Signed Written Informed Consent
- •a) Willing and able to provide informed consent.
- •2) Target Population
- •a) Subjects with SCLC documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone.
- •b) Subjects must present with extensive stage disease (VALG classification).
- •c) Eastern Cooperative Oncology Group (ECOG) performance status ? 1.
- •d) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating centers.
- •3) Age and Reproductive Status
- •a) Men and Women ? 18 years of age.
- •b) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
- •c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
- •d) Women must not be breastfeeding.
- •e) Sexually active fertile men must use effective birth control if their partners are WOCBP.
- •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 660
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 440
排除标准
- •1) Target Disease Exceptions
- •a) CNS metastases, unless non-symptomatic (ie, no neurological deficit, epilepsy or other signs and symptoms typical of CNS metastases), and not requiring treatment with steroids or anticonvulsant medications. In addition, if treated with radiation therapy, CNS metastases must be stable with no evidence of progression on scans for at least 30 days from initial radiologic diagnosis of CNS metastases.
- •b) Malignant pleural effusion that is recurrent despite appropriate supportive care.
- •2) Medical History and Concurrent Diseases
- •a) Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment such as: i) Ulcerative colitis and Crohn?s disease, ii) Rheumatoid arthritis, systemic progressive sclerosis (scleroderma),
- •iii) Systemic Lupus Erythematosus, iv) Autoimmune vasculitis (eg, Wegener?s Granulomatosis).
- •b) Subjects with history of motor neuropathy considered of autoimmune origin (eg, Guillain-Barré Syndrome).
- •c) Subjects with a history of toxic epidermal necrolysis (TEN).
- •d) Interstitial pneumonia or pulmonary fibrosis.
- •e) Paraneoplastic autoimmune syndrome
- •f) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires.
- •g) Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy.
- •h) Prior malignancy, active within 5 years, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- •i) HIV, active Hepatitis B, or active Hepatitis C infection, based on testing performed during the CA184156 screening period. In the event of a positive HIV or anti-HCV antibody test, results of confirmatory testing must be awaited before randomization.
- •j) Prior systemic therapy for lung cancer, including vaccines and other targeted therapies.
- •i) Prior radiation therapy or loco-regional surgeries are allowed if performed at least 3 weeks prior to the start of study therapy.
- •k) Subjects with ? Grade 2 peripheral neuropathy.
- •3) Physical and Laboratory Test Findings
- •a) Inadequate hematologic function defined by:
- •i) Absolute neutrophil count (ANC) < 1,500/mm3, or
- •ii) Platelet count < 100,000/mm3; or
- •iii) Hemoglobin level < 9 g/dL.
- •b) Inadequate hepatic function as defined by either:
- •i) Total bilirubin level ? 2.5 times the ULN;
- •ii) AST and ALT levels ? 2.5 times the ULN.
- •c) Inadequate renal function defined as calculated creatinine clearance < 50 ml/min based on the standard Cockroft and Gault formula.
- •d) Sodium (Na) < 130 mmol/l.
- •4) Prohibited Treatments and/or Therapies
- •a) Chronic use of immuno-suppressive drugs (ie, corticosteroids used in the
- •management of cancer or non-cancer related illnesses). Use of corticosteroids are allowed if used as premedication for chemotherapy administration or on-study management of an AE.
- •b) Any non-oncology vaccine therapy used for prevention of infectious disease (for up to 4 weeks prior to or after any dose of blinded study drug).
- •c) Any immunotherapy for the treatment of cancer.
- •d) Prior treatment with any inhibitor or agonist of T-cell co-stimulation.
- •5) Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated.
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