A Study of Hospital-at-Home for People Receiving Tarlatamab

Description

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).

Conditions

Small-cell Lung Cancer, Small Cell Lung Carcinoma

Study Overview

Study Details

Study 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).

MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery

A Study of Hospital-at-Home for People Receiving Tarlatamab

Condition
Small-cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk- Commack (Consent Only), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Consent only), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activites), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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
  • * 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 deemed inappropriate by treating physician
  • * No exclusion criteria

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Robert Daly, MD, MBA, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2028-04-23