New combo therapy aims to shrink lung tumors without chemo or surgery
NCT ID NCT07224152
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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