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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Small-cell Lung Cancer; Small Cell Lung Carcinoma

Treatments: Other: Hospital-at-Home/HAH

Study type: Interventional

Funder types: Other

Identifiers

NCT06957314

25-077

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Participants randomized to the control group will receive administration of tarlatamab and subsequent inpatient monitoring according to MSK SOP

Hospital-at-Home/HAH Intervention Arm

Experimental group

Description:

Participants randomized to the Hospital-at-Home/HAH arm will have regular home visits by a SeniorCare community paramedic.

Treatment:

Other: Hospital-at-Home/HAH