A Study of Hospital-at-Home for People Receiving Tarlatamab
- Conditions
- Small-cell Lung CancerSmall Cell Lung Carcinoma
- Registration Number
- NCT06957314
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Patient
-
Diagnosis of extensive stage small cell lung carcinoma (ES-SCLC)
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Treatment plan of commercially available tarlatamab monotherapy as standard of care
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Patients must be 18 years of age or older
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Eastern Cooperative Oncology Group (ECOG) performance status <2
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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.
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The patient is willing to give and sign informed consent
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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.
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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 studyPhysician
- Treating physician for patient(s) enrolled on study; managing treatment plan of commercially available tarlatamab as standard of care
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of inpatient hospital days 14 days Evaluate whether HaH in combination with an enhanced oncology specific telemedicine platform is efficient by quantifying inpatient hospital days during the two 7-day periods (14 days total) after the tarlatamab infusions scheduled for C1D1 and C1D8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering at Basking Ridge (Consent only)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
🇺🇸Uniondale, New York, United States