NCT06957314 A Study of Hospital-at-Home for People Receiving Tarlatamab
| NCT ID | NCT06957314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-23 |
| Primary Completion | 2028-04-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-04-23 with a primary completion date of 2028-04-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 any uncertainty about patient residence eligibility, the Principal Investigator will decide after discussion with SeniorCare. * Patients must be accompanied by a caregiver for the period of time the patient is enrolled in the HaH intervention. For cases where there is uncertainty, the Principal Investigator will make the final determination. Caregiver * Primary caregiver as identified by patient enrolled on study Physician * Treating physician for patient(s) enrolled on study; managing treatment plan of commercially available tarlatamab as standard of care Exclusion Criteria: Patient * Patients with a documented active infection prior to starting tarlatamab. This includes grade 3 or higher viral, bacterial, or fungal infection. * Patients with baseline dementia or cognitive barriers * Uncontrolled arrhythmias Caregiver * Caregiver deemed inappropriate by treating physician Physician * No exclusion criteria
Contact & Investigator
Robert Daly, MD, MBA
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06957314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small-cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06957314 currently recruiting?
Yes, NCT06957314 is actively recruiting participants. Contact the research team at dalyr1@mskcc.org for enrollment information.
Where is the NCT06957314 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06957314 clinical trial?
NCT06957314 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Robert Daly, MD, MBA at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 70 participants.
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