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

FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone

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