NBTXR3 + Radiation Therapy for Lung Cancer

Overseen By Aileen Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Immunotherapy, Targeted therapy

Disqualifiers: Pregnancy, Interstitial lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a new treatment, NBTXR3 (a novel therapeutic agent), combined with radiation therapy to help patients with advanced non-small cell lung cancer. It focuses on patients who cannot undergo surgery or chemotherapy. For those with stage I-III non-small cell lung cancer where surgery isn't an option, this trial might be suitable. As a Phase 1/Phase 2 trial, it provides an opportunity to be among the first to receive this new treatment and assess its effectiveness.

Will I have to stop taking my current medications?

The trial requires that you have not received any systemic therapies (like chemotherapy or immunotherapy) within 4 weeks before starting the study. You also cannot take any concurrent systemic therapies during the trial.

Is there any evidence suggesting that NBTXR3 with radiation therapy is likely to be safe for humans?

Research has shown that NBTXR3, when combined with radiation therapy, is generally safe. In a study involving 12 patients with advanced non-small cell lung cancer, the treatment was well-tolerated, with manageable side effects. The study also demonstrated that injecting NBTXR3 directly into tumors is feasible, which aids in delivering the treatment effectively.

Another study aimed to determine the optimal dose of NBTXR3 and its side effects when used with radiation therapy. This research ensures the treatment's effectiveness and safety for patients. Although still in the early stages, these results are promising for those considering participation in clinical trials with NBTXR3. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lung cancer, which typically involve chemotherapy and traditional radiation therapy, NBTXR3 is a novel radioenhancer nanoparticle. Researchers are excited about NBTXR3 because it amplifies the effects of radiation therapy directly at the tumor site, potentially increasing the effectiveness of the treatment without adding more toxicity to surrounding healthy tissues. This unique approach allows for more precise targeting of cancer cells, which could lead to better outcomes and fewer side effects compared to conventional methods.

What evidence suggests that NBTXR3 with radiation therapy might be an effective treatment for lung cancer?

Research has shown that NBTXR3, when combined with radiation therapy, could effectively treat non-small cell lung cancer (NSCLC). Studies have found that this combination enhances the effectiveness of radiation therapy. In one study, NBTXR3 and radiation together successfully eliminated primary and secondary tumors in animals, significantly improving their survival rates. Early human data also suggest that this treatment is safe and practical for patients with advanced NSCLC. Initial signs of success have appeared in other types of cancer, indicating possible benefits for lung cancer as well. Overall, these findings support the potential of NBTXR3 with radiation as a treatment for lung cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Aileen Chen, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage I-III non-small cell lung cancer who can't have chemotherapy or surgery. They must understand the study, be willing to participate, and meet certain health criteria like adequate blood counts and organ function. Pregnant women, those unable to use birth control, or patients with certain medical conditions are excluded.

Inclusion Criteria

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.

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.

My lung cancer is confirmed by biopsy and is stage I-III.

Exclusion Criteria

Known contraindication to iodine-based or gadolinium-based IV contrast.

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.

Cognitively impaired subjects

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy with NBTXR3 at varying doses to evaluate feasibility and safety

15 fractions over 3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• NBTXR3

Trial Overview The trial tests NBTXR3 combined with radiation therapy in patients ineligible for chemotherapy or surgery. It's a phase I/II study at a single institution aiming to evaluate the safety and effectiveness of this new treatment approach on advanced lung cancer.

How Is the Trial Designed?

Group I: Phase I/II: Treatment with NBTXR3 + Radiation Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Nanobiotix

Industry Sponsor

Trials

7

Recruited

950+

Citations

1. ir.nanobiotix.com ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-first-data-completed-dose-escalation-part

Release Details Data show favorable safety and confirm injection feasibility in 12 patients with locally advanced NSCLC amenable to re-irradiation for whom ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9669748/

NBTXR3 improves the efficacy of immunoradiotherapy ... This combination effectively eradicated the primary and secondary tumors and increased animal survival to 75%. Remarkably, previously treated with NBTXR3- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04505267

NCT04505267 | NBTXR3 and Radiation Therapy for the ... 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 ...

4. curetoday.com curetoday.com/view/breaking-down-the-converge-study-of-nbtxr3-in-stage-3-unresectable-nsclc

Breaking Down the CONVERGE Study of NBTXR3 in ... Key Takeaways · The CONVERGE study evaluates NBTXR3's efficacy in stage III unresectable NSCLC with standard chemoradiation and durvalumab.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.6038

Efficacy from the ongoing phase I trial Study 1100 with ... Conclusions: Promising early signs of efficacy were observed in HNSCC pts treated with NBTXR3/RT/anti-PD-1, including responses in pts resistant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07224152

NBTXR3 With Radiation Therapy Alone for Locally ... 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 ...

7. jto.org jto.org/article/S1556-0864(25)00401-0/fulltext

207P: Phase I study of reirradiation (ReRT) with NBTXR3 ... This study aimed to determine the safety, feasibility, and recommended phase II dose (RP2D) of intra-tumoral NBTXR3 with reRT.

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-04580

NBTXR3 and Radiation Therapy for the Treatment of ... 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 ...

9. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/nanobiotix-data-from-two-phase-1-nbtxr3-studies-at-elc/

Nanobiotix Data from Two Phase 1 NBTXR3 Studies at ELC Positive data could significantly advance the development of NBTXR3 in lung cancer, potentially leading to improved outcomes for patients who ...