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:

• Adults aged 18 or older who are able to give their informed consent to participate
• People who have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be cured, confirmed by laboratory testing of cells or tissue, with a specific gene change (mutation) in the EGFR gene that makes the cancer sensitive to a drug called osimertinib (note: certain types of EGFR mutations, such as exon 20 insertions, are not eligible — confirm with trial site)
• People whose cancer is mainly of a type called adenocarcinoma (certain other subtypes are not eligible)
• People whose cancer has continued to grow while being treated with osimertinib, where osimertinib was part of the most recent treatment, and where the treating doctor considers it appropriate to continue osimertinib at 80 mg daily
• People whose cancer shows a protein called c-MET at intermediate or high levels, measured from a tumour sample taken after the cancer grew on osimertinib, or within 4 months before joining the trial (as long as the sample was taken after osimertinib was started), using a specific approved laboratory test
• People who have at least one area of measurable cancer, as defined by standard imaging guidelines (RECIST 1.1)
• People who are generally well enough to carry out daily activities with no or minimal limitations, as rated by a standard medical scale (ECOG score of 0 or 1)
• People who are able to swallow oral medication, have no known intolerance to the study drugs, and are able to follow the study requirements
• People whose blood test results meet specific minimum levels for white blood cells, platelets, and haemoglobin (the trial site will assess these)
• People whose kidney function meets a minimum level, based on blood or urine tests (the trial site will assess this)
• People whose liver function tests are within acceptable ranges (the trial site will assess this)
• People whose blood protein (albumin) level meets a minimum threshold (the trial site will assess this)
• Women who could become pregnant must have a negative pregnancy test before joining, and must agree to use a highly effective method of contraception from the start of screening until 7 months after the last dose of one of the study drugs (telisotuzumab vedotin); women who cannot become pregnant due to age, surgical sterilisation, or confirmed menopause may meet this requirement differently (confirm with trial site)
• Men who have sexual contact with a woman who could become pregnant, or who is pregnant or breastfeeding, must agree to use a condom throughout treatment and for 4 months after the last dose of telisotuzumab vedotin
• All participants must agree not to donate sperm or eggs during the trial and for a set period after the last dose (4 months for men, 7 months for women)

Who may not be able to join:

• People currently enrolled in another clinical trial that involves active treatment (participation in a follow-up phase or an observational study may be acceptable — confirm with trial site)
• People who have previously been treated with a specific type of therapy that combines a c-MET targeting antibody with a microtubule-disrupting toxin (such as MMAE); other types of prior MET-targeted treatments may be acceptable (confirm with trial site)
• People who have received chemotherapy, immunotherapy, biological therapy, hormonal cancer therapy, or other experimental cancer treatments within the past 3 weeks, or within 5 half-lives of that medication, whichever is the shorter period (hormones used for non-cancer conditions such as insulin or hormone replacement therapy are generally acceptable)
• People who have received significant radiation to the chest (30 Gy or more) within the past 6 months, or any other radiation within the past 2 weeks (some exceptions may apply for certain targeted bone treatments — confirm with trial site)
• People whose brain metastases (cancer spread to the brain) are growing or causing symptoms; people with stable, treated, symptom-free brain metastases on a stable or reducing dose of steroids may be eligible; people with cancer spread to the lining of the brain (leptomeningeal disease) are not eligible
• People who have not yet recovered from significant side effects of previous cancer treatments (minor or stable low-grade side effects may be acceptable — confirm with trial site)
• People with a history of certain lung conditions, including lung scarring (pulmonary fibrosis), inflammation of the lung (pneumonitis) from any cause, or who show signs of active lung inflammation on a recent CT scan
• People who have had major surgery or serious physical injury within 4 weeks before starting the trial, or who are expected to need major surgery within 4 weeks after the first dose
• People who have an active infection currently requiring intravenous antibiotics or antifungal medication; people with a well-controlled history of HIV, hepatitis B, or hepatitis C may be eligible if certain conditions are met (confirm with trial site)
• People with a history of another cancer diagnosed within the past 2 years, with some exceptions for certain early-stage or fully treated cancers unlikely to affect the trial results (confirm with trial site); people currently receiving any ongoing anti-cancer treatment, including maintenance therapy, are generally not eligible (some hormonal therapies may be acceptable — confirm with trial site)
• People with serious uncontrolled medical conditions, including but not limited to: uncontrolled heart rhythm problems, heart attack or stroke within the past 6 months, significant nerve damage, significant swelling (oedema or lymphoedema), significant fluid build-up in the abdomen or around the lungs, significant eye problems, uncontrolled seizures, or a psychiatric condition that prevents giving informed consent
• People who are unwilling or unable to follow the trial procedures
• People who, in the opinion of the trial doctor, have any condition that could interfere with assessing the treatment or interpreting results safely

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