Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • 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. For peripheral lesions, cytology and/or clear imaging-guided suspicion is accepted if histology cannot be obtained.
  • ECOG performance status of 0-3.
  • Large (>3cm) or centrally localized (within 2cm in all directions around the proximal bronchial tree, including ultra-central tumors, abutting the bronchial tree or trachea), node negative and non-metastatic NSCLC, judged acceptable for SBRT by the treating Investigator. Staged with FDG-PET/CT, brain CT or MRI with contrast and/or mediastinoscopy, measurable disease as defined by RECIST 1.1.
  • Adequate end-organ function, based on routine clinical and laboratory workup:
    1. ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 8.0 g/dl
    2. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
    3. Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
    4. International normalized ratio (INR) (or prothrombin time (PT)) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, if values are within the intended therapeutic range
  • 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).

• Key Exclusion Criteria

  • Subjects with confirmed nodal and/or distant disease(including brain), according standard workup by local investigator
  • Subjects with peripheral lesions 3cm or smaller
  • Prior treatment with immunotherapy
  • Prior intra-thoracic radiotherapy or surgery with substantial overlap in former 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.
  • 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.
  • Subjects unable to lie down with arms up with a regular breathing pattern.
  • 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.
  • Participation in other clinical trials either to treat diagnosed lung cancer or to reduce the toxicity of therapy from participating in GC4711 clinical trial.
  • 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.
  • Female subjects who are pregnant or breastfeeding.
  • Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.