Recruiting NCT06957314
A Study of Hospital-at-Home for People Receiving Tarlatamab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hospital-at-Home/HAH.
- Who it may be relevant to
- Registry conditions: Small-cell Lung Cancer, Small Cell Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery
Overview
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
- Other Hospital-at-Home/HAH
After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence
Primary outcome measures
- Number of inpatient hospital days [Time frame: 14 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale
Identifiers
NCT: NCT06957314 · 25-077