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

Bristol-Myers Squibb141 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

141

Conditions

Non Small Cell Lung Cancer

Interventions

BMS-690514DRUG

Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity

ErlotinibDRUG

Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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+

Locations (30)

Outcomes

Primary Outcomes

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

Time frame: CT/MRI at baseline and every 6 weeks for 36 weeks

Secondary Outcomes

To compare the overall survival between BMS-690514 and erlotinib

Time frame: 15 months

To estimate the overall response rate of BMS-690514 or erlotinib

Time frame: 15 months

To estimate the tumor size change and PFS rate at 6 weeks

Time frame: 6 weeks

To assess safety and tolerability of BMS-690514 and erlotinib

Time frame: 15 months

To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib

Time frame: 15 months

To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients

Time frame: Days 1,8,15, 29

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.