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

Plain English Summary

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer is a Phase 2 clinical trial sponsored by M.D. Anderson Cancer Center studying Locally-Advanced Non-Small Cell Lung Cancer. This trial tests a new treatment called NBTXR3 combined with standard radiation therapy for lung cancer. It is for patients with locally advanced non-small cell lung cancer who cannot have chemotherapy or surgery. Participation involves receiving an injection of NBTXR3 followed by radiation therapy. Alternatives include standard chemotherapy, surgery, or palliative care, depending on the patient's specific situation. The trial aims to enroll 40 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of non-small cell lung cancer. Patients must be medically unable to undergo surgery or chemotherapy, or choose not to. Good general health is required, with specific blood count and organ function requirements. Individuals with certain lung conditions, prior radiation to the chest, or active infections cannot participate. This trial is studying Locally-Advanced Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how safe the treatment is by tracking any side effects and adverse events, helping to understand the risks involved. The specific primary outcome measures are: Safety and Adverse Events (AEs) (Through study completion; an average of 1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a gap in treatment for lung cancer patients who are not candidates for current standard therapies, offering a potential new option to improve outcomes. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Locally-Advanced Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial explores a novel approach for a significant cancer type, with potential for improved efficacy and market penetration if successful, though it is an early-phase study. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about how NBTXR3 is injected and what radiation therapy involves. Understand the schedule of visits for injections, radiation, and follow-up appointments. Be prepared for potential side effects and discuss any concerns with your healthcare team. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 40 participants

Interventions

• DRUG: NBTXR3 — Given by injection

Primary Outcomes

• Safety and Adverse Events (AEs) (Through study completion; an average of 1 year)

Full Eligibility Criteria

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

Trial Locations

• The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer
• Thoracic Oncology
• Radiation Oncology
• Cancer Treatment
• Advanced Cancer
• Inoperable Cancer
• Oncology
• Pulmonary Oncology
• Medical Oncology

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