Clinical trial NCT06957314: A Study of Hospital-at-Home for People Receiving Tarlatamab
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small-cell Lung Cancer
Small Cell Lung Carcinoma
Keywords: Small-cell Lung Cancer
Small Cell Lung Carcinoma
Tarlatamab
Memorial Sloan Kettering Cancer Center
25-077
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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 studyPhysician
* 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

Primary outcomes:
measure: Number of inpatient hospital days
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Robert Daly, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: