Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer

Exclusion Criteria

• •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