FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens

Inclusion Criteria:

- Histologically or cytologically confirmed stage IIIB or IV NSCLC

- Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic
NSCLC

- At least one target lesion that is unirradiated and measurable by RECIST

- Adequate hematologic, renal and hepatic function

- ECOG 0, 1, or 2

- 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

- 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 affect compliance or follow-up in the protocol

- Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to
randomization or previous radiotherapy to the target lesion sites (the sites that are
to be followed for determination of a response)

- 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 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