Recruiting

HaH with Tarlatamab

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06957314

Conditions

Small-cell Lung Cancer

Small Cell Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hospital-at-Home/HAH

Study Details

Brief summary:

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).

Conditions

Small-cell Lung Cancer

Small Cell Lung Carcinoma

Study ID

NCT06957314

Start date

Apr 23, 2025

Status verified date

Jun, 2026

Completion date

Apr 23, 2028

Anticipated

Primary completion date

Apr 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control Arm

Participants randomized to the control group will receive tarlatamab administration as per usual care.

experimental: Hospital-at-Home/HAH Intervention Arm

Participants randomized to the intervention group will receive tarlatamab administration through the hospital-at-home care delivery model.

Interventions

Hospital-at-Home/HAH

After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence

Primary outcome measure

  • Number of inpatient hospital days [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Robert Daly, MD, MBA

646-608-3789dalyr1@mskcc.org

Michael Offin, MD

646-608-3763offinm@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Robert Daly, MD, MBA

646-608-3789

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Robert Daly, MD, MBA

646-608-3789

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Small-cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Tarlatamab
  • Memorial Sloan Kettering Cancer Center
  • 25-077
  • extensive stage small cell lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-12.