A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

Phase 2

Completed

Brief Summary: The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Recruitment & Eligibility

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 contraception
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 disease
History of use of other TKIs
Uncontrolled hypertension
HIV+

Arm && Interventions

Group	Intervention	Description
A1	BMS-690514	-
B2	Erlotinib	-

Primary Outcome Measures

Name	Time	Method
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib	CT/MRI at baseline and every 6 weeks for 36 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the overall survival between BMS-690514 and erlotinib	15 months
To estimate the overall response rate of BMS-690514 or erlotinib	15 months
To estimate the tumor size change and PFS rate at 6 weeks	6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib	15 months
To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib	15 months
To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients	Days 1,8,15, 29

Locations (10): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Hema/Oncology Assoc. Of Nepa
🇺🇸
Dunmore, Pennsylvania, United States
Cancer Center Of The Carolinas
🇺🇸
Greenville, South Carolina, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Yale University School Of Medicine
🇺🇸
New Haven, Connecticut, United States
Mass General Hospital
🇺🇸
Boston, Massachusetts, United States
Hematology Oncology, P.C.
🇺🇸
Stamford, Connecticut, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Piedmont Hematology Oncology Associates, Pllc
🇺🇸
Winston-salem, North Carolina, United States
Local Institution
🇨🇳
Taipei, Taiwan