RECRUITING

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

Conditions

Small-cell Lung Cancer Small Cell Lung Carcinoma Tarlatamab Memorial Sloan Kettering Cancer Center 25-077

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2025-04-23

Study Completion:2028-04-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06957314

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Robert Daly, MD, MBA

CONTACT

646-608-3789

dalyr1@mskcc.org

Michael Offin, MD

CONTACT

646-608-3763

offinm@mskcc.org

Principal Investigator

Robert Daly, MD, MBA

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065

United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-23

Study Completion Date2028-04-23

Study Record Updates

Study Start Date2025-04-23

Study Completion Date2028-04-23

Terms related to this study

Keywords Provided by Researchers

Small-cell Lung Cancer
Small Cell Lung Carcinoma
Tarlatamab
Memorial Sloan Kettering Cancer Center
25-077

Additional Relevant MeSH Terms

Small-cell Lung Cancer
Small Cell Lung Carcinoma