Confirmed locally advanced or metastatic non-small cell lung cancer that is unresectable
At least 1 unirradiated target lesion measurable by RECIST
Adequate hematologic, renal and hepatic function
ECOG 0,1
Able to understand and sign an Informed Consent
You may not be if
Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
Received prior systemic anti-cancer therapy for NSCLC
History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin or the chemotherapy drugs
Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥5 years
Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
Serious active infection
Psychiatric illness/social situations that would limit study compliance
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic
Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or previous radiotherapy at the indicator sites (the sites that are to be followed for determination of a response)
Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
Known HIV positive or on active anti-retroviral therapy
Known Hepatitis B surface antigen positive or hepatitis C positive
Receipt of any investigational medication within 4 weeks prior to randomization
Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and for 30 days after completion of treatment
Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
