NBTXR3 + Radiation Therapy for Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Chemotherapy, Immunotherapy, Targeted therapy
Disqualifiers: Interstitial lung disease, Pneumonitis, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
This phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.
Do I need to stop my current medications for this trial?
The trial requires that you stop taking any approved or investigational cancer treatments, like chemotherapy or immunotherapy, at least 3 weeks before starting the trial. However, there might be exceptions for certain medications with short half-lives after discussion with the trial team.
What data supports the effectiveness of the treatment NBTXR3 + Radiation Therapy for Lung Cancer?
Radiotherapy is a key treatment for non-small cell lung cancer (NSCLC), and new techniques like intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy (SRT) are being developed to improve outcomes. Combining radiation therapy with other treatments, such as immunotherapy, has shown promise in enhancing the body's immune response against tumors, suggesting potential benefits for lung cancer patients.12345
Is NBTXR3 with radiation therapy safe for humans?
The safety of radiation therapy techniques like image-guided radiation therapy (IGRT) and stereotactic body radiation therapy (SBRT) has been a focus of research, showing that these methods are generally safe and have progressed significantly in clinical practice. However, specific safety data for NBTXR3 combined with radiation therapy is not provided in the available research articles.678910
What makes the NBTXR3 + Radiation Therapy treatment unique for lung cancer?
The NBTXR3 + Radiation Therapy treatment is unique because it uses a nanoparticle radioenhancer (NBTXR3) to boost the effects of radiation therapy, potentially improving survival and creating long-term immune memory against tumors, even in cases resistant to other treatments like anti-PD1 therapy.15111213
Eligibility Criteria
This trial is for adults with inoperable, recurrent non-small cell lung cancer who've had radiation therapy over 6 months ago. They must be able to undergo a specific type of injection and have up to 4 treatable lung lesions. Participants need proper organ function and performance status (ECOG 0-2), may have limited additional cancer lesions, and must not be on other systemic cancer therapies or part of another clinical trial.Inclusion Criteria
My last radiation treatment was over 6 months ago.
I can take care of myself and am up and about more than half of the day.
My doctor says I cannot have surgery for my condition.
See 9 more
Exclusion Criteria
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.
I am using effective birth control methods during the study.
I am not pregnant or breastfeeding.
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients receive NBTXR3 intratumorally or intranodally on day 1, followed by radiation therapy 5 times weekly over 3 weeks
3 weeks
15 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Every 3 months
Long-term follow-up
Participants are monitored for long-term outcomes and late onset toxicities
3 years
Every 6 months
Treatment Details
Interventions
- NBTXR3 (Radio-enhancer)
- Radiation Therapy (Radiation)
Trial OverviewThe study tests the optimal dose and side effects of NBTXR3 nanoparticles when used with radiation therapy. NBTXR3 aims to enhance the effect of radiotherapy on tumor cells without increasing damage to healthy tissue. The goal is more effective tumor shrinkage while sparing surrounding areas.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (NBTXR3, RT)Experimental Treatment2 Interventions
Patients receive NBTXR3 IT or intranodally on day 1. Within 15 days, patients undergo RT 5 times weekly (Monday-Friday) over 3 weeks for a total of 10-15 fractions.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Prospective Study of Patient-Reported Symptom Burden in Patients With Non-Small-Cell Lung Cancer Undergoing Proton or Photon Chemoradiation Therapy. [2018]Intensity-modulated radiation therapy (IMRT), three-dimensional conformal radiation therapy (3DCRT), and proton-beam therapy (PBT) are chemoradiotherapy modalities for treating locally advanced non-small-cell lung cancer. Although therapy is carefully planned to maximize treatment benefit while minimizing risk for adverse side effects, most patients develop radiation-induced symptom burden.
Immunotherapy with radiotherapy fails to improve prognosis of patients with stage IV non-small cell lung cancer: a retrospective cohort analysis of the THUNDER-2 study. [2023]Radiotherapy (RT) may enhance the systemic antitumor reaction to immunotherapy (IT). Currently, the effect of RT in stage IV non-small cell lung cancer (NSCLC) patients treated with IT is uncertain. This study aimed to confirm the role of RT in these patients.
Clinical experiences of combining immunotherapy and radiation therapy in non-small cell lung cancer: lessons from melanoma. [2020]Radiation therapy (RT) is an essential component of local control for non-small cell lung cancer (NSCLC), but distant failures dictate the poor prognosis of this disease. Until recently, the possibility of using RT as an immunoadjuvant to stimulate a systemic anti-tumor immune response was not a realistic clinical opportunity. The emergence of immune checkpoint blockade as an effective immunotherapy for NSCLC has opened the door for combinatorial approaches involving RT. In melanoma, the body of preclinical evidence combining radiation and immunotherapy buoyed clinical efforts, from which promising results have begun to emerge. Preclinical work combining radiation and immunotherapy indicate similar findings in NSCLC, and clinical efforts are ongoing. Here, we review the rationale, preclinical evidence, ongoing efforts and anticipated challenges of efforts combining radiation and immunotherapy in NSCLC.
Current landscape of palliative radiotherapy for non-small-cell lung cancer. [2020]Radiotherapy (RT) is a cornerstone in the management of advanced stage III and stage IV non-small-cell lung cancer (NSCLC) patients. Despite international guidelines, clinical practice remains heterogeneous. Additionally, the advent of stereotactic ablative RT (SABR) and new systemic treatments such as immunotherapy have shaken up dogmas in the approach of these patients. This review will focus on palliative thoracic RT for NSCLC but will also discuss the role of stereotactic radiotherapy, endobronchial brachytherapy (EBB), the interest of concomitant treatments (chemotherapy and immunotherapy), and the role of RT in lung cancer emergencies with palliative intent.
[Radiotherapy for non-small cell lung cancer]. [2009]Radiotherapy is a major therapeutic option in non small-cell lung cancer. Concurrent chemoradiation is the standard treatment of locally advanced unresectable tumours. Current modalities of thoracic radiotherapy include three-dimensional conformal techniques, allowing dose escalation and combination with new generation cytotoxic drugs to occur. New techniques of radiotherapy are currently under development: respiratory gating and intensity-modulated techniques may allow a better focalisation of the ballistics; stereotactic radiotherapy and proton-beam radiotherapy, less available in Europe at the time, would be indicated in the exclusive treatment of early-stage tumours in non-operable patients.
Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. [2021]The combination of intensity modulated radiation therapy (IMRT) and image guided radiotherapy (IGRT) plays a significant role in sparing normal tissue during prostate cancer treatment. We report the clinical outcomes of 260 patients treated with high-dose IGRT as well as the toxicity of high-dose IGRT in these patients.
Comparison of MR-guided radiotherapy accumulated doses for central lung tumors with non-adaptive and online adaptive proton therapy. [2023]Stereotactic body radiation therapy (SBRT) of central lung tumors with photon or proton therapy has a risk of increased toxicity. Treatment planning studies comparing accumulated doses for state-of-the-art treatment techniques, such as MR-guided radiotherapy (MRgRT) and intensity modulated proton therapy (IMPT), are currently lacking.
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Proton stereotactic body radiation therapy for clinically challenging cases of centrally and superiorly located stage I non-small-cell lung cancer. [2021]To minimize toxicity while maintaining tumor coverage with stereotactic body radiation therapy (SBRT) for centrally or superiorly located stage I non-small-cell lung cancer (NSCLC), we investigated passive-scattering proton therapy (PSPT) and intensity-modulated proton therapy (IMPT).
Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. [2022]This study aimed to evaluate the toxicity of prostate and pelvic lymph node stereotactic body radiation therapy (SBRT) for high-risk prostate cancer.
A radioenhancing nanoparticle mediated immunoradiation improves survival and generates long-term antitumor immune memory in an anti-PD1-resistant murine lung cancer model. [2022]Combining radiotherapy with PD1 blockade has had impressive antitumor effects in preclinical models of metastatic lung cancer, although anti-PD1 resistance remains problematic. Here, we report results from a triple-combination therapy in which NBTXR3, a clinically approved nanoparticle radioenhancer, is combined with high-dose radiation (HDXRT) to a primary tumor plus low-dose radiation (LDXRT) to a secondary tumor along with checkpoint blockade in a mouse model of anti-PD1-resistant metastatic lung cancer.
Intensity-modulated radiation therapy (IMRT) for inoperable non-small cell lung cancer: the Memorial Sloan-Kettering Cancer Center (MSKCC) experience. [2022]Intensity-modulated radiation therapy (IMRT) is an advanced treatment delivery technique that can improve the therapeutic dose ratio. Its use in the treatment of inoperable non-small cell lung cancer (NSCLC) has not been well studied. This report reviews our experience with IMRT for patients with inoperable NSCLC.
Current radiotherapy techniques in NSCLC: challenges and potential solutions. [2021]Introduction: Radiotherapy is an important therapeutic strategy in the management of non-small cell lung cancer (NSCLC). In recent decades, technological implementations and the introduction of image guided radiotherapy (IGRT) have significantly increased the accuracy and tolerability of radiation therapy.Area covered: In this review, we provide an overview of technological opportunities and future prospects in NSCLC management.Expert opinion: Stereotactic body radiotherapy (SBRT) is now considered the standard approach in patients ineligible for surgery, while in operable cases, it is still under debate. Additionally, in combination with systemic treatment, SBRT is an innovative option for managing oligometastatic patients and features encouraging initial results in clinical outcomes. To date, in inoperable locally advanced NSCLC, the radical dose prescription has not changed (60 Gy in 30 fractions), despite the median overall survival progressively increasing. These results arise from technological improvements in precisely hitting target treatment volumes and organ at risk sparing, which are associated with better treatment qualities. Finally, for the management of NSCLC, proton and carbon ion therapies and the recent development of MR-Linac are new, intriguing technological approaches under investigation.