EUCTR2009-017396-19-DE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
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
- 920
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 cerval 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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