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A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

Inclusion Criteria:

- ECOG PS of 0 or 1

- Histologically confirmed NSCLC

- Adequate amount of tumor (archived or fresh) for biomarker evaluation

- Received one to two regimens of chemotherapy (with at least one platinum-containing)

- Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater
than 60 mL/min

- Stable control of blood pressure on agents other than calcium channel blockers

- Women of child-bearing potential must avoid pregnancy or maintain adequate

- Must be able to swallow pills and take the medications at the same time every day on
an empty stomach

Exclusion Criteria:

- ECOG PS 2 or greater

- Women unwilling to avoid pregnancy or use adequate contraception

- Symptomatic brain metastases

- Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)

- History of hemoptysis greater than 10 mL/day

- Significant cardiovascular disease

- Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive

- History of use of other TKIs

- Uncontrolled hypertension

- HIV+

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare the progression-free survival of patients on BMS-690514 with those on erlotinib

Outcome Time Frame:

CT/MRI at baseline and every 6 weeks for 36 weeks

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

June 2012

Related Keywords:

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



Memorial Sloan Kettering Cancer Center New York, New York  10021
Henry Ford Hospital Detroit, Michigan  48202
Hematology Oncology, P.C. Stamford, Connecticut  06902
Oregon Health & Science University Portland, Oregon  97201
Yale University School Of Medicine New Haven, Connecticut  06520
Cancer Center of the Carolinas Greenville, South Carolina  29615
Mass General Hospital Boston, Massachusetts  02114
Piedmont Hematology Oncology Associates, PLLC Winston-Salem, North Carolina  
Hema/Oncology Assoc. Of Nepa Dunmore, Pennsylvania  18512