Hospital-at-Home program for patients receiving Tarlatamab
MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery
This study is testing if a Hospital-at-Home program can help adults with advanced small cell lung cancer who are getting tarlatamab feel better while being monitored from home instead of staying in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | tarlatamab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06957314 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with extensive stage small cell lung carcinoma who are receiving tarlatamab.
Not a fit: Patients with severe comorbidities or those who cannot maintain adequate organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more convenient and efficient way for patients to receive care after treatment.
How similar studies have performed: Similar studies exploring home-based care models have shown promise, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- 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)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.