SCCA Clinical Studies: Lung Cancer
BMS-936558 versus Docetaxel for Non-squamous Non-small Cell Lung Cancer (UW12017)
An Open-label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|Closed||Lung Cancer||Phase III||
The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.
Eligibility Criteria (must meet the following to participate in this study)
- Men & women = 18 years of age
- Subjects with histologically or cytologically-documented locally advanced non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection
- Disease recurrence or progression during/after one prior platinum-containing doublet chemotherapy regimen for advanced or metastatic disease
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status = 1
- A formalin fixed, paraffin-embedded (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
Exclusions (conditions that would prevent participation in this study)
- Subjects with active Central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are adequately 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)
- Subjects with carcinomatous meningitis.
- Subjects with active, known or suspected autoimmune disease, or subjects with interstitial lung disease
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
- Prior therapy with anti-programmed death-1 (anti-PD-1), anti programmed cell death ligand 1 (anti-PD-L1), anti programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Prior treatment with Docetaxel
- Treatment with any investigational agent within 28 days of first administration of study treatment
Last UpdatedMay 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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