Phase 1 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 have been fully informed about the study, agree to take part, and are able to follow the study requirements, including signing a consent form
• People aged 18 to 75 years old at the time of signing the consent form, of any sex
• People who have been confirmed by tissue or cell testing to have advanced small cell lung cancer or neuroendocrine carcinoma — specifically, those whose cancer has come back, gotten worse, or who could not tolerate prior treatment; for small cell lung cancer, prior treatment must have included a platinum-based chemotherapy combined with an immune checkpoint inhibitor; for neuroendocrine carcinoma, prior treatment must have included platinum-based chemotherapy; certain combined or mixed tumour types are also included (confirm with trial site)
• People who have at least one measurable area of cancer that can be tracked, as confirmed by scans taken within 4 weeks before starting the trial
• People whose general health and ability to carry out daily activities meets a specific score (called ECOG 0–1), assessed within 7 days before starting the trial
• People whose expected survival is greater than 3 months
• People who have waited the required amount of time since their last treatment before joining — at least 28 days since major surgery, certain radiation therapy, chemotherapy, immunotherapy, or biological treatments; at least 14 days since targeted therapy or hormone therapy; at least 7 days since certain traditional Chinese medicines or minor surgery; and whose side effects from previous treatment have largely resolved (confirm specific timing requirements with trial site)
• People who agree to provide a stored tumour tissue sample (preferably from within the last 2 years) or agree to have a new biopsy taken, so that a specific protein called DLL3 can be tested
• People whose blood test results show their organs (such as liver, kidneys, and bone marrow) are functioning well enough, as checked within 7 days before starting the trial, and who have not received certain blood-boosting treatments in the 14 days before starting
• People of childbearing potential who agree to use at least one highly effective form of contraception during the study and for at least 6 months after the last dose; female participants of childbearing age must also have a negative pregnancy test within 7 days before joining

Who may not be able to join:

• People who have had another type of cancer in the past 2 years, unless it was a fully cured early-stage cervical cancer or a type of skin cancer called basal cell carcinoma
• People who previously experienced serious immune-related side effects from cancer immunotherapy, including significant lung inflammation (Grade 2 or higher), heart muscle inflammation, or other severe immune reactions that led to stopping treatment
• People with significant existing lung problems, including recent blood clots in the lungs (within 3 months), severe asthma, severe chronic obstructive pulmonary disease, lung scarring, certain autoimmune conditions affecting the lungs, previous surgical removal of a lung, or radiation-related lung inflammation in the past 6 months
• People who have had certain serious brain or nervous system conditions in the past 12 months, such as seizures, stroke (unless it is an older, stable stroke), severe brain injury, dementia, Parkinson's disease, or certain mental health or autoimmune conditions affecting the brain
• People with an active paraneoplastic syndrome (a condition where the immune system reacts to cancer and affects other parts of the body)
• People with a history of inflammation or dysfunction of the pituitary gland
• People with large, uncontrolled fluid build-ups in body cavities (such as around the lungs, in the abdomen, or around the heart) that need repeated draining
• People who have previously had a stem cell or solid organ transplant from a donor
• People who have previously received treatments targeting certain proteins called DLL3, CD3, or CD28; who have received a type of treatment called an antibody-drug conjugate (ADC); or who have had major surgery, chemotherapy, or certain other treatments within the required time period before joining (confirm specific details with trial site)
• People with a known history of serious allergic reactions to antibody-based medicines or to any ingredient in the trial treatment
• People with an active infection requiring intravenous antibiotics within 2 weeks before starting the trial
• People with poorly controlled heart or blood vessel conditions, including certain levels of heart failure, unstable chest pain, a heart attack or stroke within the past 6 months, certain abnormal heart rhythms, or high blood pressure that remains poorly controlled despite treatment
• People with active or spreading cancer in the brain or the lining of the brain — though people with small, symptom-free brain metastases (tumour spots ≤ 1.5 cm, not requiring steroids) or those with treated, stable brain metastases for at least 2 months (and off steroids for at least 3 days) may still be considered (confirm with trial site)
• People with known active or suspected autoimmune diseases — though people with autoimmune-related thyroid conditions managed with thyroid hormone replacement, or type 1 diabetes managed with insulin, may still be considered
• People who have taken high-dose steroid medicines or other immune-suppressing drugs by mouth or injection in the 14 days before starting the trial — certain limited uses of steroids (such as eye drops, inhalers, skin creams, or short-term use before contrast scans) may be acceptable (confirm with trial site)
• People with active tuberculosis
• People with a known history of immune deficiency conditions, including HIV, other inherited or acquired immune deficiencies, or a history of organ transplant
• People with active hepatitis B or hepatitis C infection, or both at the same time — people who test positive for certain hepatitis B markers may still be considered if their virus levels are below a specified threshold and they agree to antiviral treatment; people who test positive for hepatitis C antibodies must also have virus levels below a specified threshold (confirm details with trial site)
• People who have received a live vaccine within 28 days before starting the trial
• People who are pregnant or currently breastfeeding
• People whom the trial doctor considers unsuitable for any other medical or safety reason

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