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

NCT07224152 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-0692NCI-2025-08155
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally-Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Phase I/II: Treatment with NBTXR3 + Radiation Therapy

EXPERIMENTAL

Drug: NBTXR3

Interventions

NBTXR3 DRUG

Given by injection

Phase I/II: Treatment with NBTXR3 + Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years.
• ECOG Performance Status 0-2
• Biopsy proven stage I-III NSCLC.
• Participant deemed medically inoperable by the investigator or treating physician, or patient declines surgery.
• 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.
• 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.
• 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.
• Adequate screening laboratory values
• 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

You may not qualify if:

• Unable to undergo NBTXR3 injection via bronchoscopic or CT-guided approach
• Unable to undergo radiation therapy for any reason
• 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.
• At screening, past medical history of:
• Interstitial lung disease
• Drug related pneumonitis
• Radiation therapy to lung or other intrathoracic organs (e.g. prior breast radiation okay)
• Has received any approved or investigational anti-neoplastic or immunotherapy agent within 4 weeks prior to NBTXR3 injection
• Receipt of more than 1 line of systemic therapy prior to RT
• 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 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, recent severe pulmonary infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Nanobiotix: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Aileen Chen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aileen Chen, MD

CONTACT

713-745-6293; achen6@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)