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

An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.

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