Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07224152

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-06

40

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

Nanobiotix

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form indicating understanding and willingness to participate
  • Age 18 years or older
  • ECOG Performance Status between 0 and 2
  • Biopsy-proven stage I-III non-small cell lung cancer
  • Medically inoperable or patient declines surgery
  • No prior or concurrent systemic therapies within 4 weeks of injection; up to 1 prior systemic therapy allowed before radiation
  • Able to undergo bronchoscopic or CT-guided injection of NBTXR3 into up to 4 lung lesions including primary tumor and involved lymph nodes
  • Target lesions measurable on cross-sectional imaging with nodal lesions at least 15 mm in short axis
  • Adequate lab values: Hemoglobin ≥ 8.0 g/dL, ANC ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Creatinine ≤ 1.5 x upper limit of normal, Creatinine clearance ≥ 30 mL/min, Total Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 3.0 x upper limit of normal or ≤ 5.0 x if liver metastases present, Serum albumin ≥ 3.0 g/dL
  • Negative urine or serum pregnancy test within 7 days before NBTXR3 injection in females of child-bearing potential
Not Eligible

You will not qualify if you...

  • Unable to undergo NBTXR3 injection via bronchoscopic or CT-guided approach
  • Unable to receive radiation therapy for any reason
  • Pregnancy or breastfeeding
  • Women of child-bearing potential and their male partners unwilling or unable to use effective contraception during study
  • Any condition that the investigator believes would compromise participant well-being or interfere with study assessments
  • History of interstitial lung disease, drug-related pneumonitis, or prior radiation therapy to lung or intrathoracic organs (except prior breast radiation)
  • Receipt of any anti-neoplastic or immunotherapy agent within 4 weeks before NBTXR3 injection
  • More than one prior line of systemic therapy before radiation therapy
  • Use of concurrent systemic therapy or participation in another therapeutic clinical trial
  • Known allergy or contraindication to iodine-based or gadolinium-based contrast agents
  • Active malignancy other than locoregional recurrent NSCLC, except certain treated cancers relapse-free for specified times
  • Uncontrolled illnesses including active infections, recent severe pulmonary infection, symptomatic heart failure, unstable angina, renal failure, arrhythmia, or psychiatric illness limiting compliance
  • Known active uncontrolled HIV or hepatitis B or C infection
  • Cognitive impairment preventing study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Aileen Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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