A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer
Overview
Overview
GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B NSCLC, SCLC treatable with chemoradiotherapy.
Key Inclusion Criteria
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply
- 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
Key Exclusion Criteria
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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
Learn More
Learn More
Contact Us
Contact Us
To learn more about this study please contact Clinical Research
(864) 560-6812