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