An Open-Label Randomized Phase III Trial of 936558 (Nivolumab) versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)Pharmacogenetics Blood Sample Protocol Amendment 01 version 1.0 dated 12-Jun-12Revised Protocol 00d-UK specific, incorporating protocol amendments 09 and 10

Bristol-Myers Squibb International Corporation0 个研究点目标入组 320 人开始时间: 2012年7月24日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•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.
•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

•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.

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