Status:
RECRUITING
A Study of Hospital-at-Home for People Receiving Tarlatamab
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Small-cell Lung Cancer
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 (inpatie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06957314
Start Date
April 23 2025
End Date
April 23 2028
Last Update
July 3 2025
Active Locations (7)
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1
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
Commack, New York, United States, 11725