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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)

Phase 3
18 Years
Open (Enrolling)
Squamous Cell Non-small Cell Lung Cancer

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Trial Information

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)

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

Objective Response Rate is defined as the number of subjects with a Best overall response (BOR) of CR or PR divided by the number of randomized subjects

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:




Start Date:

October 2012

Completion Date:

August 2015

Related Keywords:

  • Squamous Cell Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Swedish Cancer Institute Seattle, Washington  98104
Winthrop University Hospital Mineola, New York  11501
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Seattle Cancer Care Alliance Seattle, Washington  98109
City of Hope Duarte, California  91010
Duke University Medical Center Durham, North Carolina  27710
South Carolina Oncology Associates Columbia, South Carolina  29201
Yale University New Haven, Connecticut  06520
The Johns Hopkins University Baltimore, Maryland  21287
University of Chicago Medical Center Chicago, Illinois  60637
University of Texas Southwestern Medical Center Dallas, Texas  
Vanderbilt Ingram Cancer Center Nashville, Tennessee  37232
Local Institution Phoenix, Arizona  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
St Mary Medical Center Langhorne, Pennsylvania  19047
Guthrie Clinic, Ltd Sayre, Pennsylvania  18840
West Virginia University-Mbrcc Morgantown, West Virginia  26506-9162