A Study of Hospital-at-Home for People Receiving Tarlatamab (NCT06957314) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Hospital-at-Home for People Receiving Tarlatamab
United States70 participantsStarted 2025-04-23
Plain-language summary
The purpose of this study is to find out whether a Hospital-at-Home (HaH) program is a more efficient way to monitor people's health after receiving tarlatamab than monitoring in the hospital (inpatient).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient
* Diagnosis of extensive stage small cell lung carcinoma (ES-SCLC)
* Treatment plan of commercially available tarlatamab monotherapy as standard of care
* Patients must be 18 years of age or older
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
* ANC ≥ 1000 cells/μL (without granulocyte colony stimulating factor support within 4 weeks prior to Cycle 1, Day 1)
* Platelet count ≥50,000/μL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
* Hemoglobin ≥8.0 g/dL (without transfusion within 4 weeks prior to Cycle 1, Day 1)
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 X upper limit of normal (ULN). Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL/min using the CKD-EPI formula.
* The patient is willing to give and sign informed consent
* Appropriate homebound setting as defined by one of the following:
* Lodging at MSK Residence or hotel
* 5 New York City boroughs, lower Westchester County (northern boundary Cross County Parkway) and Nassau County (eastern boundary Wantagh State Parkway). This is based on the community paramedic (SeniorCare) 60-minute response time catchment area. If there is an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is looking at whether tarlatamab can be given safely at home instead of in a hospital, what does 'hospital-at-home' actually mean in practice — would I have nurses or medical staff visiting me at my house, and how quickly could I get help if something went wrong?
2Tarlatamab can cause cytokine release syndrome, which sometimes requires close monitoring — given that risk, does my doctor think my specific health situation makes me a good or a poor candidate for receiving this drug outside of a traditional hospital setting?
3The main thing this trial is measuring is the number of days spent in the hospital — does that mean the goal is to reduce my inpatient time, and how would my care team handle it if I needed to be admitted urgently during a home treatment cycle?
4This trial is listed as Phase NA, which suggests it may be more focused on how care is delivered than on testing whether tarlatamab itself works — so would I still have access to tarlatamab through standard care or another trial if this study isn't the right fit for me?
5What are the logistical demands of participating — for example, how far do I need to live from the hospital, do I need a caregiver at home during infusions, and how does that fit with my current living situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.