Hospital-at-Home program for patients receiving Tarlatamab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a Hospital-at-Home (HaH) program for patients with extensive stage small cell lung carcinoma (ES-SCLC) who are receiving tarlatamab as part of their treatment. The goal is to determine if monitoring patients' health at home is more efficient than traditional inpatient hospital monitoring. Eligible participants must be adults with adequate organ function and performance status, and they will be monitored remotely after receiving their treatment. The study is conducted at Memorial Sloan Kettering Cancer Center locations in New Jersey.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Robert Daly, MD, MBA — Memorial Sloan Kettering Cancer Center
• Study coordinator: Robert Daly, MD, MBA
• Email: dalyr1@mskcc.org
• Phone: 646-608-3789

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cirtuvivint plus irinotecan for relapsed small-cell lung cancer

  This trial will test whether adding cirtuvivint to irinotecan helps people with relapsed small-cell lung cancer respond better and live longer.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT07155200

• Tarlatamab in strong-performance-status small-cell lung cancer

  This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.

  Recruiting at 8 sites Phase 2 AIO-Studien-gGmbH · Berlin and 7 other locations · NCT07803848

• Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy

  This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.

  Recruiting at 9 sites Phase 3 Amgen · Orlando, Florida and 8 other locations · NCT07778316

• Tarlatamab plus ZL-1310, with or without durvalumab, for small cell lung cancer

  This trial will test whether combining tarlatamab with ZL-1310, with or without the PD-L1 drug durvalumab, is safe and tolerable for adults with small cell lung cancer who have received platinum chemotherapy or are newly diagnosed extensive-stage after one cycle of chemo.

  Recruiting at 27 sites Phase 1 Amgen · Goodyear, Arizona and 26 other locations · NCT07531095

• Autologous B7-H3 CAR T Cells in Advanced Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer

  This study tests a patient’s own B7-H3 CAR T cells to see if they can help people 18 and older whose small cell lung cancer or EPNEC has come back or hasn’t responded to prior treatment.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07509034

• Tarlatamab for Small Cell Lung Cancer with Brain Metastases

  This phase II study tests whether tarlatamab can help adults with small cell lung cancer that has spread to the brain, by treating both systemic disease and brain tumors.

  Recruiting at 3 sites Phase 2 Maastricht University Medical Center · Amsterdam and 3 other locations · NCT07402343

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.