Small-cell Lung Cancer, Small Cell Lung Carcinoma
Conditions
Keywords
Small-cell Lung Cancer, Small Cell Lung Carcinoma, Tarlatamab, Memorial Sloan Kettering Cancer Center, 25-077, extensive stage small cell lung cancer
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).
Interventions
OTHERHospital-at-Home/HAH
After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTRobert Daly, MD, MBA
CONTACTMichael Offin, MD
PRINCIPAL_INVESTIGATORRobert Daly, MD, MBA
Memorial Sloan Kettering Cancer Center
Outcome results
None listed