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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Participants randomized to the control group will receive tarlatamab administration as per usual care. | |
| Hospital-at-Home/HAH Intervention Arm | Experimental | Participants randomized to the intervention group will receive tarlatamab administration through the hospital-at-home care delivery model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital-at-Home/HAH | Other | After discharge, a SeniorCare community paramedic will provide a home visit to the participant's home or residence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of inpatient hospital days | Evaluate whether HaH in combination with an enhanced oncology specific telemedicine platform is efficient by quantifying inpatient hospital days during the two 7-day periods (14 days total) after the tarlatamab infusions scheduled for C1D1 and C1D8 | 14 days |
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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:
The patient is willing to give and sign informed consent
Appropriate homebound setting as defined by one of the following:
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
Physician
Exclusion Criteria:
Patient
Caregiver
Physician
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Daly, MD, MBA | Contact | 646-608-3789 | dalyr1@mskcc.org | |
| Michael Offin, MD | Contact | 646-608-3763 | offinm@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Daly, MD, MBA | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |