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Complete title: 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)
|Research Study Number||20121428|
|Principal Investigator||Laura Chow|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
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