Phase 2 Thyroid 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 aged 18 or older
• People with a confirmed diagnosis of small cell lung cancer (SCLC) that has spread or cannot be surgically removed, regardless of DLL3 protein levels in the tumour (this applies to one group in the trial)
• People with certain other poorly differentiated neuroendocrine cancers (aggressive cancers that start in hormone-producing cells, from any part of the body) or high-grade medullary thyroid cancer, where the tumour tests positive for the DLL3 protein (this applies to a second group in the trial)
• People whose tumour type and diagnosis has been reviewed by a specialist cancer pathologist, and whose tumour meets specific growth-rate measurements (confirm with trial site for full details)
• People with high-grade medullary thyroid cancer classified according to an international grading system (confirm with trial site)
• People who have already received at least one prior treatment, including a platinum-based chemotherapy, and whose cancer has continued to grow despite standard treatment — specific prior treatment requirements differ depending on the cancer type (confirm with trial site)
• People with a type of prostate-related neuroendocrine cancer who have received appropriate prior hormone or chemotherapy treatments depending on how their cancer developed (confirm with trial site)
• People who are well enough to carry out basic daily activities, as measured by a standard performance scale (ECOG score of 2 or below)
• People with an expected survival of at least 3 months
• People who have at least one tumour that can be measured on a scan using standard criteria
• People who have a tumour that can be safely biopsied, and who agree to provide tumour and blood samples before, during, and at the end of treatment
• People whose blood test results show the bone marrow, kidneys, liver, and other organs are functioning well enough, based on tests done within 21 days before starting treatment (confirm with trial site for specific values)
• People whose blood oxygen level is above 90% while breathing normal room air
• People who are able to understand, sign, and date a consent form before any trial procedures begin, and who are willing and able to attend study visits
• People who are covered by a social security or equivalent health system
• Women who could become pregnant must have a negative pregnancy blood test at the start of the trial and must agree to use a reliable form of contraception — or avoid heterosexual intercourse — during the trial and for at least 60 days after the last dose of the study drug (confirm with trial site for the full list of accepted methods)
• Women must agree not to donate or retrieve eggs for personal use from the start of the trial until at least 60 days after the final dose
• Men must either be surgically sterile, agree to avoid heterosexual intercourse, or use reliable contraception during the trial and for at least 60 days after the last dose
• Men must agree not to freeze or donate sperm from the start of the trial until at least 60 days after the final dose

Who may not be able to join:

• People who are unwilling to provide blood and tissue samples as required by the trial
• People whose cancer could potentially be treated with the aim of a cure
• People with well-differentiated (slower-growing) neuroendocrine tumours of any grade, pheochromocytoma, paraganglioma, or low-grade medullary thyroid cancer
• People with signs of a lung condition involving scarring or inflammation of the lung tissue (such as interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis), or where imaging raises suspicion of such a condition
• People who have previously had recurring or severe lung inflammation, or serious immune-related reactions, while being treated with immunotherapy drugs
• People with a history of serious allergic reactions to tarlatamab (the study drug) or any of its ingredients
• People who have not waited long enough after certain previous treatments before starting this trial — this includes recent radiotherapy, chemotherapy, other clinical trial drugs, major surgery, live vaccines, or steroid/immunosuppressive medications (confirm with trial site for specific waiting periods)
• People who have previously been treated with tarlatamab or any drug that specifically targets the DLL3 pathway
• People with active or symptomatic cancer spread to the brain or spinal cord that requires steroids or anti-seizure medication to manage symptoms — people with treated, stable, and symptom-free brain metastases may be considered
• People with cancer that has spread to the lining of the brain or spinal cord (leptomeningeal disease)
• People who still have unresolved significant side effects from previous cancer treatments (other than hair loss), that have not returned to a mild or baseline level
• People who have had another separate cancer within the past 3 years, with some exceptions such as certain treated skin cancers or other cancers considered cured
• People with serious uncontrolled health conditions, active infections, significant psychiatric or social circumstances, or other factors that the trial doctor considers would make participation unsuitable or unsafe
• People with signs of an active, uncontrolled infection within 7 days before the first dose
• People with significant fluid build-up around the lungs that is not being managed with a draining catheter
• People with certain significant heart conditions, including abnormal heart rhythm measurements on an ECG, reduced heart pumping function, a heart attack within the past 6 months, significant heart failure symptoms, or fluid around the heart (confirm with trial site for specific measurements)
• People who have had an arterial blood clot event such as a stroke or mini-stroke within the past 12 months
• People with an active Hepatitis B or Hepatitis C infection — people with past or resolved hepatitis infections may be considered depending on specific test results (confirm with trial site)
• People with active COVID-19 symptoms within 14 days before the first dose
• People with a current or past autoimmune or inflammatory condition diagnosed within the past 3 years, such as lupus, inflammatory bowel disease, rheumatoid arthritis, or certain others — some exceptions apply (confirm with trial site)
• People with an HIV diagnosis who are not on antiviral therapy with an undetectable viral load
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People whose personal, psychological, family, or geographical circumstances may prevent them from following the trial schedule
• People who are legally unable to give their own informed consent, or who are under guardianship or have had their liberty restricted by a legal or administrative decision
• People with a history of severe or life-threatening reactions to any immune-based therapy
• People currently participating in another clinical trial involving an experimental drug, where an insufficient amount of time has passed since their last dose (confirm with trial site for specific timeframes)

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