Phase 2 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:

• People who fully understand what the trial involves and have signed and dated a consent form by hand.
• People aged 18 or older.
• People who have been diagnosed with non-small cell lung cancer (a specific type of lung cancer) confirmed by laboratory testing of tissue or cell samples, at clinical stage II, IIIA, or IIIB (N2) as assessed by the trial doctor.
• People whose lung cancer has a specific genetic change called an EGFR exon 20 insertion mutation, confirmed by an approved local laboratory.
• People whose cancer has not gotten worse in the two weeks before signing the consent form, and who have a physical functioning score of 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines.
• People whose blood test results show that bone marrow, liver, kidneys, and blood clotting are all functioning within the levels required by the trial (the trial site can provide specific details on these values).
• Male participants who are willing to use barrier contraception (such as condoms) during the trial and for 6 months after the last dose, and who agree not to donate sperm during that time.
• Female participants who agree to use contraception from the start of screening until 6 weeks after the last dose, are not breastfeeding, and have a negative pregnancy test at the start of the trial.

Who may not be able to join:

• People who have previously received any systemic cancer treatment, including radiotherapy, or who are currently taking traditional Chinese medicine or medications that strongly affect a liver enzyme called CYP3A4 and cannot stop them at least one week before starting the trial.
• People who have had another type of cancer (other than lung cancer) in the past 2 years, unless it was a fully treated skin basal cell carcinoma or cervical cancer in its earliest stage with no sign of return.
• People who still have side effects rated above a mild level (grade 1) from any previous medical procedure or treatment, such as a diagnostic biopsy (hair loss of any degree is an exception).
• People who have had a stroke or bleeding in the brain within the 6 months before starting the trial.
• People who have serious or poorly controlled heart conditions, including certain abnormal heart rhythms or electrical patterns on an ECG, a history of heart attack within the past 6 months, significant heart failure, conditions known to affect heart rhythm, or atrial fibrillation (confirm with trial site for full details).
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease), including cases caused by drugs, radiation, or immunotherapy.
• People who have ongoing severe nausea and vomiting, long-term gut problems, difficulty swallowing tablets, or who have had part of their intestine removed in a way that would prevent the study drug from being properly absorbed.
• Women who are pregnant or breastfeeding.
• People who are known to be allergic to any ingredient in the study drug, sunvozertinib.
• People who the trial doctor judges to be unable to safely take part in the trial, unable to tolerate surgery, or unlikely to follow the trial requirements.

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