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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to care for patients with extensive stage small cell lung cancer (ES-SCLC) who are receiving a treatment called tarlatamab. The study is comparing a program where patients receive care at home, called Hospital-at-Home (HaH), to traditional care in the hospital. Researchers want to see if monitoring health at home is just as effective and possibly more convenient for patients after they start treatment.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with ES-SCLC. They should be in good health overall, with specific lab results showing their organs are functioning well. Patients must also have someone to help them at home during the study. The trial is currently looking for participants, and those who join can expect to be monitored closely while receiving their treatment in a comfortable home setting. It's important to note that patients with certain health issues, like active infections or severe cognitive problems, may not be able to participate.

Gender

ALL

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