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An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Non-squamous Cell Non-small Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Squamous Cell Non-small Cell Lung Cancer

Thank you

Trial Information

An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Non-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 MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- 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

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 (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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

Overall Survival is defined as the time from randomization to the date of death

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA209-057

NCT ID:

NCT01673867

Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Swedish Cancer InstituteSeattle, Washington  98104
Winthrop University HospitalMineola, New York  11501
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
City of Hope National Medical CenterLos Angeles, California  91010
Seattle Cancer Care AllianceSeattle, Washington  98109
Duke University Medical CenterDurham, North Carolina  27710
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Yale UniversityNew Haven, Connecticut  06520
H. Lee Moffitt Cancer CenterTampa, Florida  33612
University of Chicago Medical CenterChicago, Illinois  60637
University of Texas Southwestern Medical CenterDallas, Texas  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionRome, Georgia  
Tennessee Oncology, PLLCClarksville, Tennessee  37043
St. Mary Medical CenterLanghorne, Pennsylvania  19047
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231
Oncology Hematology CareCincinnati, Ohio  45242
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Sharp Clilnical Oncology ResearchSan Diego, California  92123
Henry-Joyce Cancer CenterNashville, Tennessee  37232