Phase I Study of Reirradiation With NBTXR3 for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (NSCLC)
This phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.
• Biopsy proven locoregionally recurrent NSCLC after prior definitive radiation therapy, or patients that have imaging characteristics highly suggestive of recurrence but no pathologic or cytologic diagnosis. Pathologic diagnosis will be confirmed during the procedure to inject NBTXR3, prior to injecting the drug. If pathologic diagnosis cannot be established, the procedure will be aborted and the patient will be considered a screening failure. For stage IV patients, oligometastatic disease should be confirmed at screening. Oligometastatic disease is defined as ≤ 3 cancer lesions, not including the primary tumor.
• Participant deemed medically inoperable by the investigator or treating physician.
• Overlap between recurrent disease in need of treatment and prior radiation treatment field as determined by treating Radiation Oncologist.
∙ As a general reference, recurrent disease within 50% isodose line of prior radiation treatment field would be considered significant.
‣ Radiation treatment received more than 6 months prior to enrollment.
• Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician.
∙ Up to 4 lung lesions may be injected with NBTXR3, including the primary tumor, involved lymph node(s), and/or metastatic lesion(s).
‣ At least 1 injected lesion should be located within a reirradiation field.
‣ All injected lesions must be radiated.
• The target lesion(s) should be measurable on cross sectional imaging (RECIST 1.1).
• a. Nodal target lesions must be ≥15 mm (short axis) based on CT (slice thickness of 5 mm or less) or MRI.
• Age ≥ 18 years
• ECOG Performance Status 0-2
• For cohort 1, adequate laboratory values to receive radiation as determined by the principal investigator or treating physician.
• For cohort 2 laboratory values at screening:
∙ 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 female of child-bearing potential.
⁃ 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.
⁃ English speaking or Non-English Speaking subjects