Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

Inclusion Criteria:

* At least 18 years of age
* Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically confirmed Stage III B/IV NSCLC
* Adequate hematological, hepatic, and renal function
* Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days

Exclusion Criteria:

* Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
* Congestive heart failure
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Previous exposure to Pralatrexate
* Pregnant or breast-feeding women
* Major surgery within 14 days of enrollment
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible