Dasatinib in Advanced Squamous Cell Lung Cancer

• Types and frequency of DDR2 mutations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Characterize the types and frequency of DDR2 mutations in study patients and correlate mutation status of DDR2 with clinical characteristics and response to therapy
• Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Establish the progression-free and overall survival of patients with SCC treated with dasatinib
• Toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.

Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.

In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.

Dasatinib will be taken orally, daily in cycles of 28 days.

On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:

• Medical history and clinical exam
• Safety blood tests
• Measurement of Performance Status
• Review of pill log
• CT scans will be done every 8 weeks.

Inclusion Criteria:

• Stage III/B or IV squamous NSCLC
• Measurable disease
• Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
• ECOG performance status of 0 or 1
• Estimated life expectancy greater than 12 weeks
• Normal organ and marrow function
• Confirmed availability of archival pathology samples
• Agrees to discontinue St. Johns Wort
• Able to take medications by mouth
• Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug

Exclusion Criteria:

• Pregnant or breast-feeding
• Chemotherapy or radiotherapy within 4 weeks prior to entering study
• Receiving any other investigational agents
• Known untreated or progressive brain metastases
• History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
• Taking medications known to be potent CYP3A4 inhibitors
• Currently taking H2 inhibitors or proton pump inhibitors
• Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
• HIV positive
• Clinically uncontrolled hypertension (blood pressure > 160/110)
• Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
• Active and uncontrolled clinically significant infection
• Chronic gastrointestinal disease
• Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
• Supplemental oxygen required for current malignancy
• Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
• Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration