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

Inclusion Criteria:

• 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

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