Phase 3 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 are at least 18 years old at the time of signing the consent form
• People who have had a confirmed diagnosis of non-small cell lung cancer (a specific type of lung cancer), excluding certain subtypes such as neuroendocrine, sarcomatoid, or small cell lung cancer
• People who have had their entire visible tumor surgically removed, with no cancer cells detected at the edges of the removed tissue, through a lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy (specific types of lung surgery)
• People whose lung cancer has been classified after surgery as stage IB, II, or IIIA according to a specific international staging system (AJCC TNM version 9)
• People who have a specific gene change in their tumor — either an EGFR exon 20 insertion (Cohort 1) or an EGFR PACC mutation (Cohort 2) — confirmed by an approved laboratory
• People who are able to provide enough tumor tissue for the trial's central laboratory to confirm the gene mutation
• People who have a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People who have recovered well from their lung surgery and any prior chemotherapy, with only minor or no ongoing side effects at the time of joining the trial (confirm with trial site)
• People who have healthy enough bone marrow, liver, kidney, and other organ function within 7 days before joining the trial (confirm with trial site)
• Male participants who are willing to use barrier contraception (such as condoms) during the trial and for 6 months after the last dose, refrain from donating sperm during that period, and consider banking sperm before starting the study drug if they wish to have children in the future
• Female participants who are able to become pregnant and are willing to use reliable contraception from screening until 2 months after stopping the study drug, are not breastfeeding, and have a negative pregnancy test before starting — or who meet specific criteria confirming they cannot become pregnant, such as being post-menopausal or having had certain sterilisation procedures (confirm with trial site)

Who may not be able to join:

• People whose tumor has certain other gene changes, such as EGFR L858R, exon 19 deletion, or ALK-positive mutations, for which standard treatments already exist
• People who had only a smaller type of lung surgery, such as a segmentectomy or wedge resection
• People who have received or are planning to receive radiation therapy to the chest area for their lung cancer at any point before or during the trial
• People who have previously been treated with a type of targeted drug called an EGFR tyrosine kinase inhibitor (TKI) as part of their pre- or post-surgery treatment, or whose cancer completely disappeared in response to pre-surgery therapy
• People who are currently taking, or cannot stop taking, certain strong medications or herbal products that affect how the body processes drugs (specifically strong CYP3A inducers) within 2 weeks before joining the trial
• People who have a history of a lung condition called interstitial lung disease (ILD), drug-related lung inflammation, or lung inflammation from radiation that required steroid treatment, or who currently show signs of active ILD or lung inflammation from immunotherapy
• People with serious uncontrolled health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, chronic heart failure, active bleeding disorders, or active infections including hepatitis B, hepatitis C, or HIV
• People with certain heart-related issues, including abnormal electrical activity of the heart on an ECG, a history of atrial fibrillation (irregular heartbeat) within the past 6 months, a personal or close family history of a condition called long QT syndrome, or other factors that increase the risk of a specific type of heart rhythm problem (confirm with trial site)
• People with a history of another cancer, except for certain skin cancers, non-invasive cancers (carcinoma in situ), or other solid tumours where treatment was completed more than 5 years ago with no sign of the cancer returning
• People who have ongoing severe nausea or vomiting, a chronic bowel or digestive condition, difficulty swallowing tablets, or who have had major bowel surgery that could affect how the body absorbs the study drug
• People who have a known allergy or sensitivity to sunvozertinib (the study drug) or to similar types of drugs
• People who are directly involved in designing, planning, or running this clinical trial
• People who, in the opinion of the trial doctor, are unlikely to be able to follow the trial's requirements and procedures

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