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

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

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: BMS-690514
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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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+

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: BMS-690514<br>* Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity<br>* Other names: panHER;|
| Active Comparator: B2<br> | Drug: Erlotinib<br>* Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |