Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC

Who can take part

• Male or female subjects at least 18 years of age
• Ability to understand and the willingness to sign a written informed consent
• Histological or biopsy proven NSCLC
• ECOG performance status of 0-3
• Node negative (T1 to T3N0M0), centrally located (within 2cm in all directions around the proximal bronchial tree, including ultra-central tumors, abutting the bronchial tree or trachea) or large (>1-7cm) Non-Small Cell Lung Cancer (NSCLC), judged acceptable for SBRT by the treating Investigator
• Adequate end-organ function, based on routine clinical and laboratory workup:; ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 7.0 g/dl; Serum creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 30 ml/min; Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
• Males and females of must agree to use effective contraception starting prior to the first day of treatment and continuing after the last dose of GC4711/Placebo for 30 days (females) and 90 days (males)

Who cannot take part

• Prior treatment with immunotherapy within 3 months prior to Day 1 dosing
• Prior intra-thoracic radiotherapy or surgery with substantial overlap to planned radiation fields as determined by the treating radiation oncologist
• Subjects not recovered/controlled from prior treatment-related (chemotherapy or targeted therapy) toxicities judged by treating physician
• Participation in other clinical trials actively testing new anti-cancer treatments, unless previously written approval is provided by the Sponsor
• Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
• Subjects with confirmed nodal and/or distant disease(including brain), according standard workup by local investigator
• Uncontrolled malignancy other than lung cancer that requires active treatment or is deemed by the treating physicians to be likely to affect the subject's survival duration
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GC4711
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study
• Subjects with peripheral lesions 1cm or smaller
• Female subjects who are pregnant or breastfeeding