Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

Inclusion Criteria

• Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
• Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38>30% and/or V60>20%
• Age 18 years or older
• ECOG performance status ≤ 2
• Adequate hematologic, renal and liver function
• Use of highly effective contraception

Exclusion Criteria

• Metastatic disease
• Prior radiation therapy to the region of the study cancer
• Subjects not receiving chemotherapy
• Grade 2 or greater esophagitis at baseline
• Inability to provide information in the electronic symptom-reporting device
• Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
• Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
• Malignant tumors other than the current lung cancer within the last 5 years
• Previous diagnosis of pneumonitis
• Untreated, active infectious disease requiring systemic anti-infective therapy
• Untreated HIV or active hepatitis B/C
• Females who are pregnant or breastfeeding
• Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
• Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
• Clinically significant heart disease