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New combo therapy aims to shrink lung tumors without chemo or surgery

NCT ID NCT07224152

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests a drug called NBTXR3 given with radiation therapy for people with locally-advanced non-small cell lung cancer who cannot have chemotherapy or surgery. The goal is to see if the combination is safe and helps control the cancer. About 40 adults with stage I to III lung cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas M. D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.