EUCTR2011-004792-36-PL进行中（未招募）1 期
An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)Revised Protocol Number 04, Incorporates amendment 11Pharmacogenetics Blood Sample Protocol Amendment 01 version 1.0 dated 12-Jun-12 - CheckMate 017: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 017
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
- 320
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) men & women = 18 years of age
- •2) Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease.)
- •3) Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
- •4) Measurable disease by CT/MRI per RECIST 1.1 criteria
- •5) ECOG performance status = 1
- •6) An FFPE tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
- •Specific eligibility criteria for subjects originally randomized to the docetaxel arm B and now entering the Nivolumab Extension Phase are included in the protocol in Section 3.3.1.1 and Section 3.3.2.1.
- •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 198
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •1) Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of = 10mg daily prednisone (or equivalent)
- •2) Subjects with carcinomatous meningitis.
- •3) Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •4) Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization.
- •5) Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •6) Prior treatment on the first line study CA184104 first line NSCLC study
- •7) Prior treatment with docetaxel
- •8) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- •9) Treatment with any investigational agent within 14 days of first administration of study treatment.
- •Specific eligibility criteria for subjects originally randomized to the docetaxel arm B and now entering the Nivolumab Extension Phase are included in the protocol in Section 3.3.1.1 and Section 3.3.2.1.
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