Study on NBTXR3 with Radiation Therapy for Advanced Non-Small Cell Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07224152

Provider View

This clinical trial is testing a new treatment using NBTXR3 combined with radiation therapy for patients with advanced non-small cell lung cancer (NSCLC) who cannot undergo chemotherapy or surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining NBTXR3 with radiation therapy for patients with stage I-III non-small cell lung cancer (NSCLC) who are not candidates for chemotherapy or surgery. The study will test different doses of radiation with NBTXR3 to find the best and safest approach.

Description

This study is divided into two phases:

Phase I

  • The goal is to determine if combining NBTXR3 with radiation therapy is safe and feasible for patients with locally advanced non-small cell lung cancer (LA-NSCLC).
  • Different doses of radiation will be tested with NBTXR3 to find the safest dose.

Phase II

  • The aim is to estimate how effective radiation therapy with NBTXR3 is in treating inoperable, locally advanced NSCLC.
  • The safety of the recommended dose will also be evaluated.

Secondary Objectives

  • To assess how well the combination of radiation and NBTXR3 works in shrinking tumors in patients with inoperable, locally advanced NSCLC.
  • To evaluate the time it takes for the cancer to progress after treatment with radiation and NBTXR3.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of stage I-III non-small cell lung cancer (NSCLC).
  • Cannot undergo surgery due to medical reasons or personal choice.
  • Have not received any systemic cancer treatments within 4 weeks before starting the study, except for one prior line of therapy.
  • Able to receive NBTXR3 injections and radiation therapy.
  • Have measurable tumors on scans.
  • Meet specific blood and organ function criteria, including:
    • Hemoglobin level of at least 8.0 g/dL
    • Neutrophil count of at least 1,500/mm3
    • Platelet count of at least 100,000/mm3
    • Normal kidney and liver function tests
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Cannot receive NBTXR3 injections or radiation therapy.
  • Pregnant or breastfeeding women.
  • Women and their male partners who are not using effective birth control during the study.
  • Have certain lung diseases or have had prior radiation to the lungs.
  • Have received more than one line of systemic therapy before starting radiation therapy.
  • Currently receiving other cancer treatments or participating in another clinical trial.
  • Have allergies to certain contrast agents used in imaging tests.
  • Have another active cancer, except for certain treated skin or cervical cancers.
  • Have uncontrolled health conditions, such as infections, heart failure, or psychiatric illnesses.
  • Have active, uncontrolled HIV or hepatitis infections.
  • Have cognitive impairments that affect understanding of the study.

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