NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 34
• Participant gender: All

Summary

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 radioenhancer 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Biopsy proven locoregional recurrent NSCLC after prior definitive radiation therapy

• Participant is 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 (endobronchial ultrasound [EBUS], cone-beam computed tomography [CBCT]) or computed tomography (CT)-guided injection of NBTXR3 as per investigator or treating physician

• The target lesion(s) should be measurable on cross sectional imaging (Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 and immune-related [ir]RECIST),

• Up to 4 target lesions may be injected and reirradiated, including the primary tumor and involved lymph node(s)

• Nodal target lesions must be >= 15 mm (short axis) based on CT (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Hemoglobin >= 8.0 g/dL

• Absolute neutrophil count (ANC) >= 1,500/mm^3

• Platelet count >= 100,000/mm^3

• Creatinine =< 1.5 x upper limit of normal (ULN)

• Calculated (Calc.) creatinine clearance > 45 mL/min

• Total bilirubin =< 2.0 mg/dL

• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

• Negative urine or serum pregnancy test =< 7 days of NBTXR3 injection in all female participants 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

Exclusion Criteria:

• NSCLC with radiographic evidence of distant metastases at screening

• At screening, past medical history of:

• Interstitial lung disease

• Drug related pneumonitis

• Any grade 4 thoracic radiation related toxicity

• Unresolved radiation related

• Esophagitis

• Pneumonitis

• Bronchopulmonary hemorrhage

• Any grade

• Esophageal perforation

• Radiation associated airway necrosis

• Bronchoesophageal fistula

• Tracheoesophageal fistula

• Spinal cord myelopathy

• Has received any approved or investigational anti-neoplastic or immunotherapy agent within 4 weeks prior to NBTXR3 injection

• Note: a reduced washout window may be considered for therapies with short half-lives (e.g., kinase inhibitors) after discussion with Nanobiotix, investigational new drug (IND) medical monitor and investigator

• Use of concurrent systemic therapy (chemotherapy, immunotherapy, targeted therapy) or patient participation on another therapeutic clinical trial

• Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast

• Active malignancy, in addition to locoregional recurrent NSCLC, with the exception of definitively treated and relapse free within 1 year from diagnosis of non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitely treated and relapse free with at least 2 years elapsed since the diagnosis of the other primary malignancy

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment

• Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection

• Female patients who are pregnant or breastfeeding

• Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly

• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments