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 and are able to attend all required study visits and procedures
• Adults aged 18 or older (male or female)
• People who have been diagnosed with locally advanced or metastatic non-small cell lung cancer (including a type called sarcomatoid carcinoma of the lung) confirmed by tissue or cell testing, and who have either not received any prior drug treatment for advanced disease, or have received up to 3 lines of prior systemic treatment
• People whose tumour testing (using a specific gene test at a central laboratory) has confirmed a genetic change called a MET exon 14 skipping mutation, and who are able to provide enough blood samples for additional research testing
• People whose tumour testing shows that certain other genetic changes are absent — specifically, no EGFR mutation, no ALK rearrangement, no ROS1 rearrangement, and no KRAS mutation
• People who have at least one tumour that can be measured on scans according to standard criteria (RECIST 1.1)
• People with a general health and activity level rated as 0 or 1 on a standard scale used by doctors (ECOG scale), meaning they are fully active or have only minor restrictions
• People whose life expectancy is expected to be at least 3 months
• People whose blood test results for liver function, blood cell counts, kidney function, clotting, and other markers fall within specific acceptable ranges set by the trial
• People who are expected to be able to follow the study schedule including visits, treatments, and tests
• People of childbearing potential who agree to use effective contraception from the time of signing the consent form until 3 months after the last dose of study treatment; women of childbearing potential must have a negative pregnancy blood test within 7 days before the first dose

Who may not be able to join:

• People who are unwilling to provide tumour tissue or blood samples for genetic testing
• People who have previously been treated with a MET inhibitor or a therapy targeting a protein called HGF
• People who have brain or central nervous system (CNS) metastases that are causing active symptoms or are neurologically unstable, or that require increasing doses of steroids to control — though people with CNS metastases whose symptoms are stable and controlled may still be considered (confirm with trial site)
• People who have fluid build-up around the lungs, abdomen, or heart that is not well controlled, in the judgement of the treating doctor
• People with unstable or uncontrolled heart or blood pressure conditions, such as unstable chest pain, moderate-to-severe heart failure, or blood pressure that remains very high despite medication
• People who have had a serious blood clot event (such as a heart attack, stroke, blood clot in the lungs, or deep vein clot) within 6 months before starting the study, or who have a known bleeding disorder or significant tendency to bleed
• People with certain risk factors for a specific heart rhythm abnormality (called QT prolongation), including uncorrected low potassium levels, a hereditary long QT condition, a family history of unexplained sudden death in a close relative under age 40, or recent use of medications known to cause this heart rhythm problem
• People with significant heart rhythm problems such as complete left bundle branch block, second or third degree heart block, or other serious uncontrolled heart rhythm conditions
• People with active digestive system problems — such as ulcers, uncontrollable nausea, vomiting, diarrhoea, or poor absorption — or conditions that would prevent them from taking an oral tablet, or who have had major bowel surgery that could affect how the drug is absorbed
• People with certain active infections, including active Hepatitis B (with detectable virus levels), Hepatitis C, HIV, active syphilis, active tuberculosis, or any infection requiring systemic antibiotic or antiviral treatment within 2 weeks before the first dose
• People with a known allergy or hypersensitivity to the study drug (Vebreltinib) or to chemically similar drugs
• People currently taking warfarin or similar blood-thinning medications (with an exception for very low-dose warfarin used to prevent clots related to a central catheter)
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild or baseline level (with exceptions for hair loss, skin darkening, and certain nerve-related side effects)
• People with other serious medical conditions that, in the doctor's judgement, may increase the risk of harm from the treatment
• People who have received cancer treatment or other experimental drugs too recently before the study start date (specific waiting periods apply depending on the type of prior treatment)
• People who have had radiation therapy to the chest area within 4 weeks before starting the study, or to other areas within 2 weeks, and have not recovered from radiation-related side effects (note: palliative radiation to bone for pain relief does not require a waiting period)
• People who have had major surgery within 4 weeks before starting the study (or brain surgery within 2 weeks) and have not fully recovered, or who are expected to need major surgery during the study
• People who have been diagnosed with another cancer in the past 3 years (other than the current lung cancer), unless it was a completely removed skin cancer or a completely removed carcinoma in situ
• People who are taking certain medications that strongly affect how the liver processes drugs (strong CYP3A4 inducers or inhibitors) and cannot stop taking them at least 1 week before starting the study
• People who are currently pregnant or breastfeeding
• People who are currently taking part in another interventional clinical trial, or who have received an experimental drug within 2 weeks before the first dose
• People who, in the opinion of the doctor running the trial, have other serious conditions — such as severe immune system disorders or a history of organ transplantation — that would make participation unsafe or unsuitable

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