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:

• Adults aged 18 or older who have given their written agreement to take part before any study procedures begin.
• People with a confirmed diagnosis of small cell lung cancer (SCLC), another cancer with similar small cell features, a high-grade or poorly differentiated neuroendocrine tumour of a type known to commonly carry a protein called DLL3, or any tumour confirmed to have the DLL3 protein present (confirmed by a laboratory test of tumour tissue).
• People whose cancer has come back or stopped responding to treatment after at least one previous course of cancer therapy.
• People who are able to provide a stored tumour tissue sample; if no stored sample is available, a new biopsy may be requested, though exceptions may be considered by the trial site in certain circumstances (confirm with trial site).
• People with a general health/activity level rated 0 to 2 on a standard scale used by doctors (meaning able to carry out some or all normal daily activities, with or without some limitations).
• People with an estimated life expectancy of at least 12 weeks.
• People who have at least one measurable area of cancer that can be assessed on scans, detected within 28 days before the first treatment dose.
• People who are considered suitable to receive external beam radiation therapy to a tumour site that has not previously been irradiated, as determined by their treating doctor.
• People with previously treated brain metastases (spread of cancer to the brain) may be eligible for certain study groups, provided treatment of those brain lesions was completed at least 2 weeks before the first study dose, there is no sign of new brain cancer progression, and any brain-related symptoms have been stable for at least 7 days (confirm with trial site).
• People with previously untreated brain metastases may be eligible for the radiation-to-the-brain study group (confirm with trial site).
• People who have another cancer diagnosis (past or current) that is not expected to affect the safety of this study or the ability to assess how well the study treatment works.
• People with blood counts, kidney function, liver function, clotting, lung function, and heart function that meet minimum levels set by the trial (confirm specific values with trial site).

Who may not be able to join:

• People who have previously received the study drug tarlatamab.
• People who have received any anti-cancer treatment within 30 days before the first study dose (a shorter gap of at least 14 days may be acceptable for certain chemotherapy, provided side effects have resolved — confirm with trial site).
• People who have no tumour site suitable for radiation therapy, unless the tarlatamab monotherapy group is available and open.
• People who would require re-irradiation of a previously treated site (with some specific exceptions depending on the type of radiation previously given — confirm with trial site).
• People with cancer spread to the lining around the brain and spinal cord (leptomeningeal disease) requiring a specific type of full spinal radiation.
• People with current interstitial lung disease or active non-infectious lung inflammation (pneumonitis).
• People who previously experienced recurring or severe immune-related lung inflammation or serious immune reactions while on immunotherapy drugs.
• People with unresolved significant side effects from previous cancer treatments that have not settled to a mild level, unless the side effect is stable and longstanding hair loss, or an exception is agreed upon by both the doctor and the study sponsor.
• People who have had a heart attack or significant heart failure symptoms within the past 12 months.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within the past 12 months.
• People with signs or symptoms of an active uncontrolled infection within 7 days before the first dose (minor infections that are responding to treatment may be exceptions — confirm with trial site).
• People with a history of a condition affecting the pituitary gland (hypophysitis or pituitary dysfunction).
• People with active hepatitis B or hepatitis C infection, as determined by specific blood tests (confirm with trial site).
• People who have had major surgery requiring more than 3 days in hospital within 28 days of the first study dose.
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years, or any condition currently requiring immune-suppressing medication.
• People with HIV infection, unless they are on antiviral treatment with undetectable virus levels and are willing to undergo regular monitoring (confirm with trial site).
• People who have received a diagnosis of immune deficiency or who are currently taking steroid or other immune-suppressing medications within 7 days before the first study dose.
• People who have received a live or live-attenuated vaccine within 28 days before the first study dose, or who would need one during the study period (certain exceptions apply — confirm with trial site).
• Women who are able to become pregnant and are unwilling to use an approved contraception method during treatment and for 60 days after the last dose.
• Women who are currently breastfeeding, plan to breastfeed, or plan to become pregnant during the study or within 60 days after the last dose.
• Women who are able to become pregnant and have a positive pregnancy test at the start of the study.
• Men with a female partner who could become pregnant, who are unwilling to use contraception or abstain from sexual intercourse during treatment and for 60 days after the last dose.
• Men with a pregnant partner who are unwilling to use a condom or abstain during treatment and for 60 days after the last dose.
• Men unwilling to avoid donating sperm during treatment and for 60 days after the last dose.
• People with a known allergy or sensitivity to any ingredient in the study treatment.
• People who are unlikely to be able to attend all required study visits or complete all required procedures.
• People with any other significant medical condition that, in the treating doctor's opinion, could put them at risk or affect how well the study can be carried out.

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