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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: BMS-690514

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743938

EUDRACT #: 2008-004691-44

CA187-017

Details and patient eligibility

About

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

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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+

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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141 participants in 2 patient groups

A1

Experimental group

Treatment:

Drug: BMS-690514

B2

Active Comparator group

Treatment:

Drug: Erlotinib