MATCHES-NOVEL: A randomized controlled trial in progress of hospital-at-home (HaH) versus inpatient hospitalization for post tarlatamab monitoring.

Abstract

TPS1683 Background: Tarlatamab is a bispecific T-cell engager (BiTE) therapy approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and is the first BiTE therapy approved for a solid tumor. Due to the risk of cytokine release syndrome, patients are routinely hospitalized for ≥24 hours following each of the first two doses. These hospitalizations can pose substantial logistical, financial, and psychosocial challenges, particularly for patients in rural communities or with caregiver or employment constraints. HaH is an emerging care delivery model that provides hospital-level care in patients’ homes and has been associated with reduced readmission rates, improved patient experience, and lower cost in other populations. Whether HaH can safely and efficiently replace inpatient hospitalization for post-tarlatamab monitoring is unknown. The MAking Telehealth Delivery of Cancer Care at Home Effective and Safe (MATCHES)-Novel trial evaluates a HaH model compared with standard inpatient hospitalization following tarlatamab administration. Methods: MATCHES-Novel is an active, single-center, prospective randomized controlled trial comparing HaH with standard inpatient hospitalization for post-administration monitoring of tarlatamab in patients with ES-SCLC. Eligible patients have an ECOG performance status of 0-2, are initiating tarlatamab for an FDA-approved indication, reside within a 60-minute response catchment area, and have an available in-home caregiver. Participants are randomized 1:1 to HaH or standard inpatient monitoring following drug administration, with monitoring duration and discharge criteria aligned with institutional standards. The HaH intervention includes scheduled in-home community paramedic assessments on the day of and the day after infusion, home phlebotomy, telehealth physician oversight, patient and caregiver education, and 24/7 care escalation pathways. The primary objective is to compare efficiency, measured by the number of inpatient hospital days during the two 7-day periods after each infusion. Assuming a mean number of 4 inpatient hospital days in the control arm, enrollment of 70 patients provides ≥80% power to detect a statistically significant difference if the mean inpatient days per patient in the HaH arm is ≤2.8. Secondary objectives include safety outcomes (transfers from home to inpatient care, clinician adjudicated toxicity events) and patient, caregiver and physician reported experiences and preferences, assessed through prespecified surveys and interviews. These findings may inform future care-delivery models for administering innovative cancer therapies outside the inpatient setting, potentially improving access. The trial opened to accrual in April 2025, and 16 of the planned 70 patients have been enrolled. Clinical trial information: NCI-2025-03406 .