Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response
Inclusion Criteria:
- Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy.
Subjects must have:
- Pathologically confirmed NSCLC
- Previously received treatment with single agent Gefitinib or Erlotinib and completed
treatment at least 2 weeks prior to study entry
- Any one of the following:
- A tumor that harbors an EGFR mutation
- Objective clinical benefit from treatment with Gefitinib or Erlotinib as defined by
either documented and confirmed partial or complete response (RECIST or WHO), or
significant and durable (≥ 6 months) clinical benefit (stable disease as defined by
RECIST or WHO) Progression of NSCLC while on continuous treatment with gefitinib or
erlotinib as noted by CT/MRI increase in disease after having a confirmed partial or
complete response or evidence of ≥ 6 months of SD within 3 months of study enrollment
Exclusion Criteria:
- Symptomatic brain metastasis
- History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months)
- History of hemoptysis greater than 10 mL/day within last 30 days
- Uncontrolled or significant cardiovascular disease
- History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis
- Inability to swallow tablets, untreated malabsorption or GI surgery that results in
inability to absorb protocol therapy
- Women unwilling to avoid pregnancy or use adequate contraception
- History of allergy or adverse drug reaction to gefitinib or erlotinib