Non Small Cell Lung Cancer
Conditions
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
Interventions
DRUGBMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
DRUGErlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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+
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 compare the overall survival between 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 |
| To assess safety and tolerability of BMS-690514 and erlotinib | 15 months |
Countries
Argentina, Canada, France, Poland, South Korea, Spain, Taiwan, United States
Outcome results
None listed