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

Prior treatment

• Patients with a documented active infection prior to starting tarlatamab. This includes grade 3 or higher viral, bacterial, or fungal infection.

Other illness

• Patients with baseline dementia or cognitive barriers
• Uncontrolled arrhythmias
  • Caregiver

Other

• Patient
• Caregiver deemed inappropriate by treating physician
  • Physician
• No exclusion 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