A Study of Hospital-at-Home for People Receiving Tarlatamab
MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery
1 other identifier
interventional
70
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2025
CompletedFirst Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 23, 2028
March 27, 2026
March 1, 2026
3 years
April 25, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of inpatient hospital 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
14 days
Study Arms (2)
Control Arm
NO INTERVENTIONParticipants randomized to the control group will receive tarlatamab administration as per usual care.
Hospital-at-Home/HAH Intervention Arm
EXPERIMENTALParticipants randomized to the intervention group will receive tarlatamab administration through the hospital-at-home care delivery model.
Interventions
After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence
Eligibility Criteria
You may qualify if:
- 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
- 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.
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Daly, MD, MBA
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 4, 2025
Study Start
April 23, 2025
Primary Completion (Estimated)
April 23, 2028
Study Completion (Estimated)
April 23, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.