SCCA Clinical Studies: Lung Cancer
BMS-936558 Versus Docetaxel for Squamous Non-small Cell Lung Cancer (UW12021)
An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
|Closed||Squamous Cell Non-small Cell Lung Cancer||Phase III||
The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with 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 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 chemotherapy regimen for advanced or metastatic disease
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status = 1
- An 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 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Prior treatment on the first line study CA184104 first line NSCLC study
- Prior treatment with docetaxel
- Treatment with any investigational agent within 28 days of first administration of study treatment
Last UpdatedOctober 14, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.