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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Hospital-at-Home is a more efficient way to watch patients' health after tarlatamab treatment than a hospital stay. It is for adults with small cell lung cancer that has spread widely who plan to receive tarlatamab alone as their usual care.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be at least 18 and have small cell lung cancer that has spread widely.
  • Patients must plan to receive tarlatamab alone as their usual cancer care.
  • Patients must be fully active or able to walk and do light work despite limits on hard physical activity.
  • Blood tests within 28 days before study treatment must meet required blood cell, liver, and kidney levels. Certain blood cell growth drugs and blood transfusions are not allowed in the 4 weeks before treatment.
  • Patients must agree to join and sign a consent form.
  • Patients must stay at MSK Residence, a hotel, or an eligible home in New York City's five boroughs, lower Westchester County up to Cross County Parkway, or Nassau County up to Wantagh State Parkway. The study doctor decides uncertain cases.
  • Patients must have a caregiver with them throughout Hospital-at-Home care. Caregivers joining the study must be named by the patient as their main caregiver.
  • Doctors joining the study must treat an enrolled patient and manage their usual tarlatamab treatment.

Who can't join

  • Patients with a documented active infection before starting tarlatamab, including a severe viral, bacterial, or fungal infection.
  • Patients who already have dementia or problems with thinking or understanding.
  • Patients with an irregular heartbeat that is not controlled.
  • Caregivers whom the treating doctor finds unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

NJ

NY