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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    24
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 15 August 2021
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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 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.

Description

PRIMARY OBJECTIVE:

I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy in patients with inoperable, locoregional recurrent non-small cell lung cancer (NSCLC), previously treated with definitive radiation therapy.

SECONDARY OBJECTIVES:

I. To evaluate the safety and feasibility of reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC.

II. To evaluate the anti-tumor response of reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC.

III. To evaluate time-to-event outcomes after reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC

EXPLORATORY OBJECTIVE:

I. To assess biomarkers of response in patients treated with NBTXR3/radiation therapy (RT).

OUTLINE: This is a dose-escalation and dose-expansion study of NBTXR3.

Patients receive NBTXR3 intratumorally (IT) or intranodally on day 1. Within 15 days, patients undergo RT 5 times weekly (Monday-Friday) over 3 weeks for a total of 10-15 fractions.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for up to 5 years.

Details
Condition Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Unresectable Lung Non-Small Cell Carcinoma
Treatment radiation therapy, Hafnium Oxide-containing Nanoparticles NBTXR3, Functionalized hafnium oxide crystalline nanoparticles (NBTXR3)
Clinical Study IdentifierNCT04505267
SponsorM.D. Anderson Cancer Center
Last Modified on15 August 2021

Eligibility

 Yes No Not Sure

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
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