Obrixtamig, Carboplatin, and Etoposide for First-Line Treatment of Advanced Extrapulmonary Neuroendocrine Carcinoma in DLL3-Positive Patients

"{\n \"timeline\": [\n {\n \"step\": \"randomisation and start of trial treatment\",\n \"step_number\": \"1\",\n \"details\": [\n \"After joining the study, you are randomised, which means you are assigned by chance to one of two treatment groups.\",\n \"One group receives obrixtamig by intravenous infusion together with carboplatin and etoposide. The other group receives carboplatin and etoposide without obrixtamig.\",\n \"The trial compares these two treatment approaches in patients with advanced extrapulmonary neuroendocrine carcinoma that cannot be removed by surgery and has spread, and that has tested positive for the target marker described in the study.\"\n ]\n },\n {\n \"step\": \"study medicines given during treatment\",\n \"step_number\": \"2\",\n \"details\": [\n \"Obrixtamig is given by intravenous infusion. The source data do not state a dose, frequency, or treatment duration for this medicine.\",\n \"Carboplatin is given by intravenous infusion at a dose of 750 mg. The source data do not state how often it is given or how long it is given.\",\n \"Etoposide is given by intravenous infusion at a dose of 100 mg/m2 per dose, where m2 means square meter of body surface area. The source data do not state how often it is given or how long it is given.\"\n ]\n },\n {\n \"step\": \"monitoring during treatment\",\n \"step_number\": \"3\",\n \"details\": [\n \"During the trial, your health and the effect of treatment are checked over time.\",\n \"The study measures whether you remain alive for as long as possible after randomisation. This is called overall survival, which means the time from randomisation until death from any cause.\",\n \"The study also checks whether the cancer gets worse. This is called progression-free survival, which means the time from randomisation until the cancer first gets worse or death, whichever happens first.\",\n \"The study records whether the cancer shrinks or disappears. This is called objective response, which means a complete response or partial response based on scan and examination results.\",\n \"The study records how long a response lasts. This is called duration of response, which means the time from the first confirmed response until the cancer gets worse or death.\",\n \"The study records disease control, which means the best result seen is complete response, partial response, or stable disease. Stable disease means the cancer does not clearly grow or shrink.\",\n \"The study checks for side effects, including serious nerve or brain-related problems called CRS and ICANS. CRS means cytokine release syndrome, a strong immune reaction. ICANS means immune effector cell-associated neurotoxicity syndrome, a problem that can affect the brain and nerves.\",\n \"The study also records whether side effects lead to stopping a study medicine permanently or changing the dose, including interruption, delay, or reduction.\"\n ]\n },\n {\n \"step\": \"quality-of-life assessment at week 19\",\n \"step_number\": \"4\",\n \"details\": [\n \"By week 19, the study checks a part of your quality of life called physical functioning.\",\n \"Physical functioning means how well you can carry out everyday physical activities.\"\n ]\n },\n {\n \"step\": \"end of trial follow-up\",\n \"step_number\": \"5\",\n \"details\": [\n \"The trial continues to collect information until the study ends.\",\n \"The planned trial period runs from 26 june 2026 to 15 may 2030.\"\n ]\n }\n ]\n}"