Study of Salirasib to Treat Non-Small Cell Lung Cancer

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