APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

Inclusion Criteria:

- Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)

- Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV
NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant
setting are not eligible.

- Measurable disease by RECIST

- Greater than or equal to 18 years of age

- ECOG PS of 0 or 1

Exclusion Criteria:

- Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic
investigational agents within 4 weeks of initiating study treatment

- Evidence of NYHA class III or greater cardiac disease

- History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
within 12 months

- Known HIV infection or AIDS

- Symptomatic CNS metastases

- Pregnant or nursing women

- Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.

- History of upper GI bleeding, ulceration, or perforation

- Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC

- Previous anti-EGFR kinase therapy