Phase 3 Lung Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.

• People whose general health and ability to function day-to-day falls within an acceptable range for this type of trial (rated on a standard medical scale called ECOG/Zubrod, scores 0, 1, or 2).

• People whose scan results show signs of non-small cell lung cancer (NSCLC), including tumours that appear partly solid, where the solid part makes up 50% or more of the growth.

• People whose lung tumour has been confirmed as NSCLC by a tissue biopsy taken within the past 180 days before joining the trial.

• People with a tumour measuring 4 cm or less at its widest point, confirmed as early-stage (clinical stage IA or selected IB) by a PET scan or combined PET-CT scan of the chest and upper abdomen, performed within the past 180 days.

• People whose lymph nodes in the chest area showed suspicious signs on scans but were then confirmed to be free of cancer through a biopsy or surgical procedure performed within the past 180 days.

• People whose tumour has been assessed by a chest surgeon and confirmed to be in a location that allows for a smaller, partial lung removal (called sublobar resection) rather than removal of a full lobe.

• People whose tumour sits in the outer part of the lung, at least 2 cm away from the central airway system — centrally located tumours are not eligible.

• People with no sign that the cancer has spread to other parts of the body.

• People who have had lung function tests (breathing tests) completed within the past 180 days. In some cases, people who are physically unable to perform these tests may still be eligible if a qualified chest surgeon provides written confirmation of their suitability (confirm with trial site).

• People who are considered at high risk for major lung surgery, based on meeting at least one of the following major criteria — or, if none of the major criteria apply, at least two of the minor criteria listed below:

  Major criteria (any one qualifies):

  • A breathing test result (FEV1) showing lung capacity at 50% or less of what is expected for that person.
  • A lung gas exchange result (DLCO) at 50% or less of what is expected.
  • A qualified chest surgeon has assessed and documented that full lung lobe removal would be poorly tolerated by the patient.

  Minor criteria (any two qualify):

  • Aged 75 or older.
  • FEV1 breathing test result between 51% and 60% of expected.
  • DLCO result between 51% and 60% of expected.
  • High blood pressure in the lungs (pulmonary hypertension), confirmed by heart scan or a specific heart test.
  • Reduced heart pumping function, with an ejection fraction of 40% or less.
  • Low oxygen levels in the blood at rest or during exercise, below a certain threshold.
  • Elevated carbon dioxide levels in the blood above a certain threshold.
  • Significant breathlessness in daily life, rated 3 or higher on a standard breathlessness scale.

• People who have not previously received radiation therapy to the same side of the chest for a prior lung tumour. Previous radiation to the head, neck, breast, or other non-chest areas may be acceptable if treatment fields would not overlap. Radiation to the opposite lung may be acceptable if it was completed more than 3 years ago with no overlapping fields (confirm with trial site).

• People who have not previously received chemotherapy, radiation, or surgery specifically to treat the lung cancer being considered for this trial.

• People who have not previously had lung tissue surgically removed from the same side of the chest.

• People who are not pregnant or breastfeeding. Women who could potentially become pregnant must have a negative pregnancy test before joining. Women going through or past menopause must have had no periods for more than 12 months to be considered not at risk of pregnancy.

• People with no history of another invasive cancer, or who have been cancer-free for at least 3 years — with exceptions for certain skin cancers and non-invasive (in-situ) cancers.

• People who are able to understand and sign a written consent form agreeing to participate.

Who may not be able to join:

• People under 18 years of age.
• People whose general health status is too poor (ECOG/Zubrod score above 3).
• People whose scans show a growth that is less than 50% solid (mostly appearing as "ground glass" on imaging).
• People whose lung cancer biopsy was taken more than 180 days before joining the trial.
• People with a tumour larger than 5 cm, or whose staging scans were performed more than 180 days ago.
• People whose lymph node biopsy was performed more than 180 days before joining the trial.
• People whose chest surgeon has determined the tumour cannot be removed with a smaller, partial removal procedure.
• People with a tumour located in the central region of the lung, near the main airways.
• People with evidence that the cancer has spread to other parts of the body.
• People whose lung function tests were done more than 180 days ago, or who were unable to do the tests and do not have written documentation from a qualified chest surgeon confirming eligibility.
• People who do not meet the high-risk surgery criteria — either at least one major criterion or at least two minor criteria.
• People who have had prior radiation to the same side of the chest for a previous lung tumour, or radiation to the opposite lung completed less than 3 years ago where the treatment fields would overlap.
• People who have previously received chemotherapy, radiation, or surgery specifically for the lung cancer being considered in this trial.
• People who have previously had lung tissue removed on the same side of the chest.
• People who are currently pregnant or breastfeeding.
• People who have had another invasive cancer within the past 3 years (exceptions apply for certain skin cancers and non-invasive cancers).
• People who are unable to understand or sign a written consent form.

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