Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) With or Without GC4711 for Early Stage, Centrally Located or Large Non-Small Cell Lung Cancer (NSCLC)(GRECO-1)
Phase 1/2 Study of SBRT With or Without GC4711 for NSCLC (GRECO-1)
GTI-4711-101 is a Phase 1-2 study of the safety of GC4711, and its potential to reduce radiation-related pulmonary injury due to SBRT for early stage large or central localized NSCLC. After an open-label, Phase 1, safety cohort of approximately 5 subjects has been completed, a randomized, double-blind, placebo-controlled Phase 2 portion will be conducted.
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:
- ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 8.0 g/dl
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
- Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
- 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.
To learn more, visit ClinicalTrials.Gov
Amy Curtis, MD
Galera Therapeutics, Inc.