Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Side effects from any previous cancer treatments must have mostly resolved (to a mild level or below) before joining, except for hair loss
• Blood cell counts, liver function, and kidney function must meet specific levels measured by blood tests (confirm exact values with trial site)
• People aged 18 or older
• People diagnosed with non-small cell lung cancer (NSCLC), confirmed by tissue or cell testing
• People with stage II or III NSCLC that cannot be treated with surgery, either because of where the tumour is or because surgery is not safe for that person medically
• People with a small number of areas where cancer has spread (up to 5 sites total, with up to 10 brain spots counted as just 1 site), where the medical team recommends radiation treatment to the chest
• People whose lung cancer has come back in the chest area after previous surgery, where the medical team recommends radiation treatment
• People who have had specific scans completed, including a PET-CT scan (or CT scan of the chest, abdomen, and pelvis with contrast dye) and a brain scan (MRI preferred, or CT with contrast)
• People who have had recent blood tests, physical examination, and vital signs checked within 14 days of joining
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to care for oneself, with activity ranging from fully active to limited strenuous activity)
• People with no history of complete heart conduction block, liver disease such as cirrhosis, glaucoma, or a condition called priapism
• People who have fully healed from any chest surgery and are at least 3 weeks past that procedure before starting treatment
• People who are able to give written consent before any study procedures begin
• Women who could potentially become pregnant must have a negative pregnancy test within 14 days of joining
• Women who are breastfeeding may only participate if breastfeeding is stopped before treatment begins
• People of reproductive age must be willing to use effective contraception or abstain from sex during treatment and for 6 months after the last radiation dose
• People planning to receive chemotherapy alongside radiation must be considered suitable for standard chemotherapy by their oncologist

For the optional MRI imaging part of the trial:

• People who consent to the main trial and also agree to take part in the optional MRI imaging study

Who may not be able to join:

• People who have had a pneumonectomy (surgical removal of an entire lung)
• People with a history of active connective tissue disease (such as scleroderma) or a lung scarring condition called idiopathic pulmonary fibrosis
• People who have had previous radiation therapy in an area that would overlap with the new radiation treatment planned
• People who are breastfeeding and plan to continue during treatment, or who have a positive pregnancy test
• People with liver problems causing jaundice, or whose liver blood test results do not meet the required levels
• People with serious unstable medical or psychiatric conditions that could affect their safety or ability to follow the study, including:
  • Unstable chest pain or heart failure requiring hospital admission in the past 6 months
  • A serious heart attack in the past 6 months
  • AIDS (as defined by current health authority guidelines)
  • A severe flare-up of a lung condition, or breathing problems serious enough to require hospitalisation, within 30 days of joining
• People currently taking nitrate medications (such as nitroglycerin), or who have taken them within 30 days of starting the study treatment
• People currently taking sildenafil (Viagra) who are not willing to stop use for 2 days before starting a study drug called papaverine, throughout the study, and for 2 days after the last dose of papaverine

For the optional MRI imaging part of the trial:

• People with medical reasons they cannot have an MRI scan (such as a pacemaker, certain metal implants, aneurysm clips, or weighing more than 350 pounds)
• People with severe anxiety or claustrophobia related to MRI scanning, even with medication to help
• People who use supplemental oxygen and are unable to stop using it for a few hours at a time, or who need oxygen when lying down

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