Inclusion Criteria:
- Age 18 or older
- Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
- Measurable disease
- Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy
and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent
disease and documented KRAS mutation
- Last dose of radiotherapy > 3 weeks prior to study entry and recovered from all acute
toxicities associated with the prior therapy
- No history of another malignancy in the past 5 years except treated non-melanomatous
skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
- Karnofsky Performance status of 70 or greater
- Body Weight > 50 kg
- Life expectancy ≥ 3 months
- Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN,
alkaline phosphatase ≤ 5x ULN, WBC > 3000/mm³, ANC ≥ 1500/mm³, platelets ≥
100,000/mm³, hemoglobin ≥ 10g/dL.
- No coexisting cardiac or medical problems that would limit compliance in the study
- Willing to undergo blood sampling for pharmacokinetic analysis
- Negative pregnancy test, if applicable
Exclusion Criteria:
- Evidence of active heart disease including myocardial infarction within previous 3
months
- Active infectious process
- Active central nervous system metastases (requiring increasing doses of
corticosteroids over the prior month, known progressing lesions)
- Pregnant or lactating
- Major surgery without full recovery or major surgery within 3 weeks prior to
treatment start
- QTc Interval > 470 msec
- Gastrointestinal tract disease resulting in inability to take or absorb oral
medications