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临床试验/EUCTR2009-017396-19-AT
EUCTR2009-017396-19-AT进行中（未招募）1 期

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) - IDEATE

Bristol-Myers Squibb International Corporation0 个研究点目标入组 920 人开始时间: 2011年4月7日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
920
研究概览入排标准研究者记录与标识符相似试验

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 NSCLC of predominantly squamous histology 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 Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
  • •c) At least 1 measurable tumor lesion, as defined by mWHO criteria (section 5.4.2.2)
  • •d) Eastern Cooperative Oncology Group (ECOG) performance status = 1 at study entry
  • •e) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating centers
  • •f) Re-enrollment: permitted for a subject who has discontinued the study as a pretreatment
  • •failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be reconsented
  • •3) Age and Reproductive Status
  • •a) Men and Women = 18 years of age
  • •b) Women of childbearing potential (WOCBP) and their partners must be using highly effective method of
  • •birth control (double barrier, eg. condom or diaphragm or cervical cap associated with spermicide or intrauterine device combined with another form of birth control) for up to 8 weeks
  • •after the last dose of ipilimumab to minimize the risk of pregnancy. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of
  • •12 weeks after dosing has been completed. See Section 3.3.3 for the definition of WOCBP
  • •c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at screening and within 24 hours prior to the start of investigational product
  • •d) Women must not be breastfeeding
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 552
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 368

排除标准

  • •1) Target Disease Exceptions
  • •a) History of or current brain metastases
  • •b) Pleural effusion that cannot be controlled despite appropriate interventions
  • •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) Dementia, altered mental status, or any psychiatric condition that would prohibit
  • •the understanding or rendering of informed consent or completing questionnaires
  • •e) Serious uncontrolled medical disorder that, in the opinion of the investigator,
  • •would impair the ability of the subject to receive protocol therapy
  • •f) 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
  • •g) HIV positive or active Hepatitis B or active Hepatitis C infection based on testing done during the screening period
  • •h) Prior systemic therapy for locally advanced or metastatic lung cancer including vaccines and other targeted therapies
  • •- Prior radiation therapy or loco-regional surgeries are allowed
  • •-Adjuvant/neo-adjuvant systemic therapy for lung cancer is allowed if completed at least 1 year prior to enrollment in this study
  • •i) Subjects with = Grade 2 peripheral neuropathy
  • •j) History of allergy or hypersensitivity to any component of the treatment
  • •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 upper limit of normal (ULN);
  • •ii) AST and ALT levels = 2.5 times the ULN or = 5 times the ULN if liver
  • •metastases are present
  • •c) Inadequate renal function defined as calculated creatinine clearance < 50 ml/min
  • •based on the standard Cockroft and Gault formula
  • •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) Sex and Reproductive Status
  • •a) Sexually active fertile men not using effective birth control if their partners are
  • •6) Other Exclusion Criteria
  • •a) Prisoners or subjects who are involuntarily incarcerated
  • 另有 2 项未显示

研究者

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