NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
This is a single institution, single arm phase I/II study of NBTXR3 with radiation therapy for stage I-III advanced non-small cell lung cancer patients who are not candidates for chemotherapy or surgical resection.
• Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
• Age ≥ 18 years.
• ECOG Performance Status 0-2
• Biopsy proven stage I-III NSCLC.
• Participant deemed medically inoperable by the investigator or treating physician, or patient declines surgery.
• No prior or concurrent systemic therapies within 4 weeks of injection. Patient may receive up to 1 line of prior systemic therapy prior to starting RT.
• Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician.
• a. Up to 4 lung lesions may be injected with NBTXR3, including the primary tumor and involved lymph node(s) All injected lesions must be radiated.
• The target lesion(s) should be measurable on cross sectional imaging (RECIST 1.1), Nodal target lesions must be ≥15mm (short axis) based on CT (slice thickness of 5mm or less) or MRI.
• Adequate screening laboratory values
‣ Hemoglobin ≥ 8.0 g/dL
⁃ Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
⁃ Platelet Count ≥ 100,000/mm3
⁃ Creatinine ≤ 1.5 x upper limit of normal (ULN)
⁃ Calc. Creatinine Clearance ≥ 30 mL/min
⁃ Total Bilirubin ≤ 2.0 mg/dL
⁃ AST / ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases
⁃ Serum albumin ≥ 3.0 g/dL Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential.