Locally-Advanced Non-Small Cell Lung CancerPhase 1/2NCT07224152
NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing NBTXR3 in people with Locally-Advanced Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally-Advanced Non-Small Cell Lung Cancer
- What is being tested?
- NBTXR3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 30 Aug 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician.
- 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
- Total Bilirubin ≤ 2.0 mg/dL
- AST / ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases
- Serum albumin ≥ 3.0 g/dL Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential.
Who cannot join
- 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:
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- 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.
- Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
- Cognitively impaired subjects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Aileen Chen, MD, 713-745-6293, achen6@mdanderson.org
Aileen Chen, MD
About this study
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.
Read the detailed description
Primary Objectives:
Phase I
To evaluate the feasibility and safety of radiation therapy with NBTXR3 in LA-NSCLC with the following dose escalation:
- 45 Gy in 15 fx with NBTXR3 at 22% RP2D
- 52.5 Gy in 15 fx with NBTXR3 at 22% RP2D
- 60 Gy in 15 fx with NBTXR3 at 22% RP2D
- 60 Gy in 15 fx with NBTXR3 at 33% RP2D
Phase II
- To estimate the efficacy of radiation therapy alone with NBTXR3 in inoperable, locoregional NSCLC
- To evaluate the safety of RP2D
Secondary Objectives:
- To evaluate the anti-tumor response of radiation with NBTXR3 in patients with inoperable, locoregional NSCLC
- To evaluate time-to-event outcomes for radiation therapy with NBTXR3 in patients with inoperable, locoregional NSCL
- Being tested
- NBTXR3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTXR3Drug
Given by injection
| Study group | Role | What they receive |
|---|---|---|
| Phase I/II: Treatment with NBTXR3 + Radiation Therapy | Experimental | Not described Receives: Drug: NBTXR3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start27 Mar 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally-Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nanobiotix
- Responsible party
- Sponsor
- Investigators
- Aileen Chen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224152
- Sponsor's protocol ID
- 2025-0692
- Other IDs
- NCI-2025-08155
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07224152
- Acronym / sponsor ID
- 2025-0692
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Nanobiotix
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
Phase I
To evaluate the feasibility and safety of radiation therapy with NBTXR3 in LA-NSCLC with the following dose escalation:
- 45 Gy in 15 fx with NBTXR3 at 22% RP2D
- 52.5 Gy in 15 fx with NBTXR3 at 22% RP2D
- 60 Gy in 15 fx with NBTXR3 at 22% RP2D
- 60 Gy in 15 fx with NBTXR3 at 33% RP2D
Phase II
- To estimate the efficacy of radiation therapy alone with NBTXR3 in inoperable, locoregional NSCLC
- To evaluate the safety of RP2D
Secondary Objectives:
- To evaluate the anti-tumor response of radiation with NBTXR3 in patients with inoperable, locoregional NSCLC
- To evaluate time-to-event outcomes for radiation therapy with NBTXR3 in patients with inoperable, locoregional NSCL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I/II: Treatment with NBTXR3 + Radiation Therapy | Experimental | Drug: NBTXR3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBTXR3Given by injection | Drug | Phase I/II: Treatment with NBTXR3 + Radiation Therapy |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aileen Chen, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NBTXR3 in people with Locally-Advanced Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aileen Chen, MD (713-745-6293, achen6@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.