Phase
Condition
Small Cell Lung Cancer
Treatment
Hospital-at-Home/HAH
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 followinglaboratory results obtained within 28 days prior to the first study treatment:
ANC ≥ 1000 cells/μL (without granulocyte colony stimulating factor supportwithin 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
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 X upperlimit of normal (ULN). Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbertdisease who have serum bilirubin level ≤ 2 x ULN may be enrolled.
Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL/min using the CKD-EPIformula.
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 CrossCounty Parkway) and Nassau County (eastern boundary Wantagh State Parkway).This is based on the community paramedic (SeniorCare) 60-minute response timecatchment area. If there is any uncertainty about patient residenceeligibility, the Principal Investigator will decide after discussion withSeniorCare.
Patients must be accompanied by a caregiver for the period of time the patient isenrolled in the HaH intervention. For cases where there is uncertainty, thePrincipal 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 ofcommercially available tarlatamab as standard of care
Exclusion
Exclusion Criteria:
Patient
Patients with a documented active infection prior to starting tarlatamab. Thisincludes 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
Connect with a study center
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting

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