RecruitingPhase 1 / Phase 2

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests NBTXR3 injections with radiation therapy for stage I–III non-small cell lung cancer. It is for adults who cannot have chemotherapy or surgery, though the study rules also allow people who choose not to have surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and sign a consent form showing you understand and agree to the study.
  • Have stage I–III non-small cell lung cancer confirmed by a biopsy, which tests a tissue sample.
  • Be able to care for yourself and be up and about for at least half the day.
  • Be unable to have surgery for medical reasons, or choose not to have surgery.
  • Have had no more than one course of whole-body cancer treatment, and none within 4 weeks before the injection.
  • Be able to receive NBTXR3 through a tube into the airways or a needle guided by a CT scan. Up to 4 cancer sites may be injected, and all must receive radiation.
  • Have cancer sites that can be measured on scans. Any target lymph nodes must be at least 15 mm across their shorter side.
  • Meet the study’s blood count, kidney, and liver test limits. If you could become pregnant, have a negative pregnancy test within 7 days before the injection.

Who can't join

  • Cannot safely receive the NBTXR3 injection or radiation, or cannot receive iodine- or gadolinium-based contrast dye used for scans.
  • Are pregnant or breastfeeding. Women who could become pregnant and their male partners must agree to use highly effective birth control throughout the study.
  • Have a history of lung tissue disease, drug-related lung swelling, or radiation to the lungs or other organs inside the chest. Prior breast radiation is allowed.
  • Have had cancer drugs within 4 weeks before the injection, more than one course of whole-body cancer treatment, or plan to receive whole-body treatment during the study or join another treatment trial.
  • Have another active cancer. Some fully treated skin, cervical, or prostate cancers, and other cancers treated without return for at least 2 years after diagnosis, may be allowed.
  • Have an uncontrolled illness, such as an infection, recent severe lung infection, heart problems, kidney failure, or a mental health condition that would prevent following treatment.
  • Have active, uncontrolled HIV, hepatitis B, or hepatitis C infection.
  • Have problems with thinking or understanding, or another condition the study doctor believes would make joining unsafe or interfere with study tests.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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. 2. Age ≥ 18 years. 3. ECOG Performance Status 0-2 4. Biopsy proven stage I-III NSCLC. 5. Participant deemed medically inoperable by the investigator or treating physician, or patient declines surgery. 6. 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. 7. 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. 8. 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. 9. Adequate screening laboratory values 1. Hemoglobin ≥ 8.0 g/dL 2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 3. Platelet Count ≥ 100,000/mm3 4. Creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Calc. Creatinine Clearance ≥ 30 mL/min 6. Total Bilirubin ≤ 2.0 mg/dL 7. AST / ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases 8. Serum albumin ≥ 3.0 g/dL Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential. Exclusion Criteria: 1. Unable to undergo NBTXR3 injection via bronchoscopic or CT-guided approach 2. Unable to undergo radiation therapy for any reason 3. Female patients who are pregnant or breastfeeding. 4. 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. 5. 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. 6. At screening, past medical history of: 1. Interstitial lung disease 2. Drug related pneumonitis 3. Radiation therapy to lung or other intrathoracic organs (e.g. prior breast radiation okay) 7. Has received any approved or investigational anti-neoplastic or immunotherapy agent within 4 weeks prior to NBTXR3 injection 8. Receipt of more than 1 line of systemic therapy prior to RT 9. Use of concurrent systemic therapy (chemotherapy, immunotherapy, targeted therapy) or patient participation on another therapeutic clinical trial. 10. Known contraindication to iodine-based or gadolinium-based IV contrast. 11. 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. 12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recent severe pulmonary infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment. 13. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection 14. Cognitively impaired subjects

Study sites (1)

TX