An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small cell Lung Cancer (NSCLC) - CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Bristol-Myers Squibb International Corporation0 个研究点目标入组 700 人开始时间: 2012年12月17日最近更新: 2022年3月21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 non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for 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 3.1.3.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 580

•1) Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or 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 1 diabetes mellitus, hypothyroidism only requiring skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment 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 with docetaxel
•7) 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 3.1.3.

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