Phase 3 Lung Cancer Trial, Recruiting NCT06500481 Sponsor: NRG Oncology Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT06500481
Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with breast cancer or non-small cell lung cancer (a type of lung cancer), confirmed through a tissue or cell sample
  • People who have been newly diagnosed with leptomeningeal metastasis (cancer that has spread to the fluid and membranes surrounding the brain and spinal cord), confirmed either through a spinal fluid test showing cancer cells, or through MRI scans showing typical signs of spread along with matching symptoms — such as headaches, nausea, vomiting, confusion, difficulty walking, facial weakness, double vision, vision changes, hearing loss, limb weakness or numbness, urinary problems, back or neck pain, or constipation
  • People whose doctors consider them suitable candidates for radiation therapy to treat leptomeningeal metastasis
  • People aged 18 or older
  • People who have received financial clearance for proton therapy treatment
  • People who have had a recent body-wide imaging scan (such as a CT scan or PET/CT) as part of their standard care
  • People with a Karnofsky performance score of 60 or higher (a measure of general health and ability to carry out daily activities — confirm with trial site)
  • People who are not pregnant and not breastfeeding; those who could potentially become pregnant must have a negative pregnancy test within 14 days before joining
  • People whose blood counts and organ function meet the following levels (which may be reached with medical support such as transfusions or medications):
    • Haemoglobin (red blood cell level) of at least 8.0 g/dL
    • Neutrophil count (a type of white blood cell) of at least 1,000/mm³
    • Platelet count of at least 100,000/mm³
    • Liver enzyme levels (AST and ALT) no more than 3 times the normal upper limit
    • Total bilirubin (a liver marker) no more than 1.5 times the normal upper limit (people with a condition called Gilbert's disease without other liver problems are not excluded)

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have previously received radiation to the spinal cord or a nerve region at the base of the spine (cauda equina) above certain dose limits (confirm with trial site)
  • People who have already received any treatment specifically for leptomeningeal metastasis (prior treatment for other brain or spinal metastases that were not leptomeningeal is allowed)
  • People who have had unstable angina (severe chest pain) requiring hospitalisation in the past 3 months
  • People who have had a heart attack in the past 3 months
  • People with significant heart failure classified as New York Heart Association Class III or IV (meaning moderate to severe limitations on physical activity — confirm with trial site)
  • People who currently have an active infection being treated with intravenous (IV) antibiotics
  • People who are currently experiencing a flare-up of chronic obstructive pulmonary disease (COPD) or another serious breathing problem that would prevent participation in the study
  • People who have moderate or severe confusion or brain function impairment (grade 2 or higher encephalopathy, as defined by standard medical criteria — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
NRG Oncology
Registry
ClinicalTrials.gov
Start date
4 March 2025
Est. completion
31 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov