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:

• People who are willing to sign a consent form before any study procedures and are able to attend scheduled visits and follow the study plan.
• Adults aged 18 or older.
• People who have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC), mainly of a non-squamous type (such as adenocarcinoma), confirmed by laboratory tissue testing.
• People who do not have cancer that has spread to the brain.
• People who have had their lung cancer fully and completely surgically removed (with clear margins, meaning no cancer cells at the edges) at Stage IB, II, IIIA, or a specific subset of Stage IIIB, as classified by a standard lung cancer staging system.
• People whose tumor has been confirmed by a central laboratory to carry one of two specific gene changes (called EGFR mutations — either Ex19del or L858R) that are known to respond to a type of targeted therapy.
• People who have fully recovered from their surgery and are able to begin additional treatment (called adjuvant treatment) between 4 and 10 weeks after the operation, with complete wound healing.
• People who have a good general performance level (rated 0 or 1 on a standard medical scale) that has been stable in the two weeks before starting the study drug, and who are expected to live for more than 12 weeks.
• Women who could become pregnant must have a negative blood pregnancy test during the screening period.
• Women who could become pregnant, and men whose partners could become pregnant, must use a highly effective form of contraception throughout the study and for 3 months after treatment ends.

Who may not be able to join:

• People whose cancer could not be fully removed, whose surgical margins showed cancer cells under the microscope, who had cancer remaining after surgery, or who had only a small wedge of lung tissue removed rather than a full surgical resection.
• People with a specific type of lung tumour called upper lung groove (superior sulcus) cancer.
• People who have had their entire right lung removed.
• People who have had another cancer in the past 5 years, except for certain cancers considered fully cured by treatment (such as fully treated thyroid cancer, cervical carcinoma in situ, certain skin cancers, or breast ductal carcinoma in situ treated with radical surgery).
• People who have already received systemic anti-cancer treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or experimental treatments before joining this study.
• People who have had major surgery (such as chest, abdominal, or brain surgery) within 3 weeks before starting the study drug.
• People who have received traditional Chinese medicine with anti-tumour indications within 14 days before starting the study drug.
• People who will still need any other form of anti-cancer treatment (such as radiotherapy, other drugs, or further surgery) during the study.
• People with significant heart conditions, including: an abnormal heart rhythm reading on an ECG beyond set thresholds; a very slow heart rate; reduced heart pumping function on an ultrasound scan; uncontrolled high blood pressure; or, within the past 6 months, severe heart failure, arrhythmias requiring medication (except controlled atrial fibrillation or pacemaker-managed rhythms), severe or unstable chest pain, heart bypass surgery, heart attack, stroke, or mini-stroke (confirm with trial site for full details).
• People who have a history of, or currently have, a lung condition called interstitial lung disease (ILD), or lung inflammation from radiation that required steroid treatment.
• People who have a history of blood clots, currently have blood clots, or who the investigator considers to be at significant risk of developing blood clots.
• People with serious active infections, active hepatitis B, hepatitis C, tuberculosis, syphilis, HIV, or conditions that cause a risk of significant bleeding.
• People with serious digestive system problems that could affect how a tablet-form medicine is taken or absorbed — such as inability to swallow tablets, uncontrolled nausea or vomiting, major bowel surgery, ongoing diarrhoea, certain untreated stomach conditions, bowel obstruction, Crohn's disease, or ulcerative colitis.
• People with significantly abnormal blood test results (confirm specific thresholds with trial site).
• People who are known to be allergic to the study drugs (befotertinib or icotinib) or their ingredients.
• People currently using, or who need to use during the study, certain strong medications that significantly affect how the body processes the study drug (called strong CYP3A inhibitors or inducers) within one week before the first dose.
• People who are using the blood-thinning medication warfarin within 7 days before the first dose (a different blood thinner called low molecular weight heparin is permitted).
• People currently participating in another clinical trial, or who participated in one and received a study drug or device within 4 weeks before the first dose, or who plan to join another clinical trial during this study.
• People who received a live vaccine within 180 days before the first dose.
• People with a history of serious mental illness, substance abuse, or alcohol dependence, or any other condition or circumstance the study doctor considers may affect safe participation or the ability to give informed consent.

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