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New treatment option for Small-cell Lung Cancer
Official title A Study of Hospital-at-Home for People Receiving Tarlatamab
ClinicalTrials.gov ID: NCT06957314
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.