Phase 2 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:

• People who have been diagnosed with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be removed), confirmed by a lab test, where surgery or other curative treatments are no longer an option.
• People whose cancer has a specific gene change (mutation) in a gene called EGFR — the exact type of mutation required depends on which group (cohort) within the trial is being considered (confirm with trial site for your specific situation).
• People joining most groups in the trial who have not previously received any systemic (whole-body) treatment for their advanced or metastatic lung cancer — though some groups require prior treatment history (confirm with trial site which group applies).
• People joining one specific group (Cohort 3 or 3b) whose cancer got worse during or after treatment with a drug called osimertinib, which must have been the most recent treatment received.
• People joining one specific group (Cohort 4) who are currently receiving a drug called amivantamab (given through a drip into a vein every two weeks) as part of standard care or another programme, for at least 8 weeks, with no dose reductions.
• People joining one specific group (Cohort 7) whose cancer got worse during or after receiving both amivantamab and lazertinib together as their first-line treatment.
• People who have at least one measurable area of cancer that can be tracked on scans (not required for Cohort 4).
• People who may have had or currently have a second, separate cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial.
• People whose kidneys, liver, blood, clotting system, and heart are all functioning at an adequate level.
• People who are well enough to carry out light activity and care for themselves (measured by a standard scale called ECOG, with a score of 0 or 1).
• People joining one specific group (Cohort 6) who are considered eligible by their doctor to take blood-thinning medication (a specific type of tablet or injection) as a preventive measure during the first 4 months of treatment, and who agree to do so.
• People who agree not to donate eggs or freeze them for fertility purposes during the trial and for 6 months after the last dose of study treatment (people with the ability to become pregnant are encouraged to consider egg preservation before the trial starts, as cancer treatments may affect fertility).
• People whose EGFR mutation was identified through an approved or validated laboratory test, with a copy of that test report available in their medical records.

Who may not be able to join:

• People who have a history of a lung condition called interstitial lung disease (scarring or inflammation of the lungs), including cases caused by a drug or by radiation treatment.
• People who have previously had a severe allergic reaction to any ingredient in the study drugs being used in their group.
• People who have received a live or weakened-live vaccine within 3 months before the trial starts (standard flu shots and non-live COVID-19 vaccines are not a reason for exclusion).
• People who are currently taking certain strong medications or herbal supplements that affect how the body processes drugs (specifically, strong CYP3A4/5 inducers), and who are unable to stop taking them for a required period before starting the trial.
• People who have another active liver disease caused by an infection.
• People who have a history of significant heart or blood vessel problems, including any of the following:
  • A blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism) within the past month.
  • A heart attack, unstable chest pain, stroke, mini-stroke, or bypass surgery within the past 6 months.
  • A known inherited tendency to develop blood clots (such as a condition called Factor V Leiden) — for groups that may include lazertinib.
  • A past blood clot in a vein and not currently on appropriate blood-thinning treatment — for groups that may include lazertinib.
  • An abnormal heart rhythm measurement on an ECG (a heart tracing), or a serious heart rhythm condition.
  • Uncontrolled high blood pressure (above specific levels measured at the clinic).
  • Severe heart failure (NYHA class III–IV), or a hospital admission for heart failure within 6 months of starting the trial.
  • Inflammation of the sac around the heart, or fluid around the heart causing symptoms.
  • Inflammation of the heart muscle.
  • A lower-than-normal pumping function of the heart, as measured by a scan before the trial begins.
• People who currently have brain metastases (cancer that has spread to the brain) that are causing symptoms. People whose brain metastases have been treated and are stable, with no symptoms, for at least 2 weeks before screening may still be considered — particularly if they are not taking steroids, or are on a low dose (confirm with trial site).
• People with squamous cell type non-small cell lung cancer are excluded from certain groups (Cohorts 2, 3, 3b, and 7).

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