Hospital-at-Home for Small Cell Lung Cancer

Recruiting at 6 trial locations

Overseen By Michael Offin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Tarlatamab

Disqualifiers: Active infection, Dementia, Arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Hospital-at-Home (HaH) program provides better health monitoring after receiving the cancer treatment tarlatamab, compared to hospital-based monitoring. Tarlatamab treats individuals with extensive stage small cell lung cancer. The study includes two groups: one remains in the hospital for monitoring, while the other receives monitoring at home. Individuals with this type of lung cancer, who have a treatment plan involving tarlatamab and reside in specific areas of New York, may be eligible. As an unphased trial, this study offers a unique opportunity to contribute to innovative care approaches for lung cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Hospital-at-Home program is safe for monitoring patients after receiving tarlatamab?

Research has shown that tarlatamab, a treatment for small cell lung cancer (SCLC), has been studied for its safety and effectiveness. Earlier studies found that tarlatamab offers a good balance between benefits and risks for patients who have already tried other treatments. It worked well, but some side effects occurred.

Some studies reported higher rates of certain side effects, such as cytokine release syndrome (CRS) and neurotoxicity (ICANS), especially during the first treatment cycle. CRS can cause fever and inflammation, while ICANS can affect the brain, leading to confusion or trouble speaking. These side effects appeared more frequently in real-world settings than in clinical trials.

Overall, tarlatamab is considered a promising treatment for SCLC and is approved for use when other treatments have not worked. This approval suggests it is generally well-tolerated, but patients should be aware of possible side effects and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tarlatamab for small cell lung cancer because it offers a new way of delivering cancer care. Unlike traditional treatments that require patients to visit the hospital, tarlatamab can be administered through a hospital-at-home care model. This innovative approach could make treatment more accessible and comfortable for patients by allowing them to receive care in their own homes while maintaining the effectiveness of the current standard of care.

What evidence suggests that the Hospital-at-Home program is effective for monitoring small cell lung cancer patients after receiving tarlatamab?

Studies have shown that tarlatamab, a drug that helps the immune system target cancer cells, has promising results for small cell lung cancer (SCLC). In the DeLLphi-300 and DeLLphi-301 trials, patients with advanced SCLC lived longer. Most patients responded well to tarlatamab, even after trying other treatments. In this trial, participants will receive tarlatamab either through the hospital-at-home care delivery model or as per usual care. These findings suggest that tarlatamab could effectively manage SCLC. ^{2 6 7 8 9}

Who Is on the Research Team?

Robert Daly, MD, MBA

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with extensive stage small cell lung cancer (ES-SCLC) who are being treated with tarlatamab. They must have good blood counts, liver and kidney function, a caregiver, and be able to consent. People can't join if they have active infections, dementia or cognitive issues, uncontrolled heart rhythm problems, or an unsuitable caregiver.

Inclusion Criteria

Patient must have ANC ≥ 1000 cells/μL, Platelet count ≥50,000/μL, Hemoglobin ≥8.0 g/dL, ALT and AST ≤ 3 X upper limit of normal, Serum bilirubin ≤ 1.5 x ULN, eGFR ≥ 30mL/min

The patient is willing to give and sign informed consent

Primary caregiver as identified by patient enrolled on study

Exclusion Criteria

Caregiver deemed inappropriate by treating physician

I do not have an active infection before starting tarlatamab.

I do not have dementia or significant cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tarlatamab with monitoring either in the hospital or at home

14 days

Regular home visits by a SeniorCare community paramedic for HaH arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tarlatamab

Trial Overview The study is testing whether monitoring patients at home after receiving tarlatamab (Hospital-at-Home program) is more efficient than traditional in-hospital care. It involves patients with ES-SCLC who meet specific health criteria and have a primary caregiver.

How Is the Trial Designed?

Group I: Hospital-at-Home/HAH Intervention Arm Experimental Treatment 1 Intervention

Participants randomized to the intervention group will receive tarlatamab administration through the hospital-at-home care delivery model.

Group II: Control Arm Active Control 1 Intervention

Participants randomized to the control group will receive tarlatamab administration as per usual care.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

This ongoing phase II clinical trial is evaluating the combination of serplulimab with chemotherapy (etoposide and carboplatin) in 36 patients with transformed small cell lung cancer (T-SCLC) that originated from EGFR-mutant non-small cell lung cancer (NSCLC).

The primary goal of the study is to assess progression-free survival, with secondary goals including overall survival and safety, addressing the urgent need for effective treatments in this aggressive cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Phase II Trial of Combined Serplulimab and Chemotherapy in Patients with Histologically Transformed Small Cell Lung Cancer: a Prospective, Single-arm and Multicentre Study. Huang, J., Zhang, XH., Cai, Y., et al.[2023]

Tarlatamab, a bispecific T-cell engager targeting DLL3 in small-cell lung cancer (SCLC), showed a manageable safety profile with 90.7% of patients experiencing treatment-related adverse events, including cytokine release syndrome in 52% of patients.

The treatment demonstrated an objective response rate of 23.4% and a median duration of response of 12.3 months, indicating promising antitumor activity in heavily pretreated SCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. Paz-Ares, L., Champiat, S., Lai, WV., et al.[2023]

In a study of 47,351 small cell lung cancer (SCLC) patients, chemotherapy was associated with a significant survival benefit, with median overall survival of 9.6 months for those treated versus 3.6 months for those untreated.

While the use of chemotherapy increased over time, the effectiveness of chemotherapy on survival showed a modest decline, indicating that while treatment is beneficial, other factors may also be influencing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends, predictors, and impact of systemic chemotherapy in small cell lung cancer patients between 1985 and 2005. Behera, M., Ragin, C., Kim, S., et al.[2018]

Tarlatamab is a promising investigational treatment for small cell lung cancer, specifically targeting the delta-like ligand 3 protein, and has shown effectiveness in patients whose cancer progressed after previous therapies.

Despite its potential benefits, there are concerns regarding the administration challenges of tarlatamab, which may affect its acceptance by clinicians and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tarlatamab Shows Promise in SCLC. [2023]

In a review of 77 patients with relapsed small cell lung cancer, 23 had pre-existing interstitial lung disease (ILD), and intravenous topotecan treatment was associated with a significant risk of acute exacerbation of ILD (AE-ILD), occurring in 21.7% of these patients.

Topotecan treatment led to severe adverse events, including neutropenia and thrombocytopenia, with AE-ILD being fatal in 3 out of 5 cases, highlighting the need for caution when administering this drug to patients with ILD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topotecan monotherapy for relapsed small cell lung cancer patients with pre-existing interstitial lung disease. Enomoto, Y., Inui, N., Imokawa, S., et al.[2015]

In a study of 518 patients with extensive small cell lung cancer (SCLC) receiving atezolizumab plus chemotherapy, the median overall survival was 11.3 months, with 46.7% of patients alive at 12 months, indicating the treatment's effectiveness in a real-world setting.

The study demonstrated that 23.6% of patients continued atezolizumab treatment beyond disease progression, suggesting a potential strategy for improving outcomes, particularly in patients with better performance status (PS 0/1) who had a median overall survival of 12.2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness and treatment sequences in patients with extensive stage small cell lung cancer receiving atezolizumab plus chemotherapy: Results of the IFCT-1905 CLINATEZO real-world study. Falchero, L., Guisier, F., Darrason, M., et al.[2023]

In the CASPIAN trial, first-line treatment with durvalumab plus platinum-etoposide significantly improved overall survival in patients with extensive-stage small cell lung cancer, showing consistent benefits regardless of PD-L1 expression or tissue tumor mutational burden status.

The study found that while PD-L1 expression may be a useful biomarker for treatment response, the overall survival benefit of durvalumab plus EP was similar across different PD-L1 subgroups, indicating that this treatment could be effective for a broad range of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab ± tremelimumab + platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): outcomes by PD-L1 expression and tissue tumor mutational burden. Paz-Ares, L., Garassino, MC., Chen, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06957314

NCT06957314 | A Study of Hospital-at-Home for People ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S152573042500052X

Real-World Outcomes of Tarlatamab in Small Cell Lung ... Tarlatamab, a bispecific T-cell engager, has shown promising results in previously treated small cell lung cancer (SCLC) patients in the DeLLphi-300 and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12459094/

Efficacy outcomes between tarlatamab and real-world ... The DeLLphi-301 trial of tarlatamab demonstrated promising survival among patients with extensive stage small-cell lung cancer (ES-SCLC), but it ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/604875

A Study of Hospital-at-Home for People Receiving ... 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 ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8106

Implementation of tarlatamab treatment for small cell lung ... Results: From June 2024 to January 2025, 29 patients with SCLC were treated, 27 of whom completed cycle 2 at data cut-off and were evaluated for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40280845/

Real-World Outcomes of Tarlatamab in Small Cell Lung ... We observed higher rates of CRS and ICANS during the first treatment cycle suggesting that real-world safety outcomes may differ from clinical trial data.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e20127

Real-world safety and efficacy of tarlatamab in patients with ... Tarlatamab (T), a bi-specific T-cell engager, is approved for use in extensive stage SCLC after progression on a platinum-based chemotherapy ...

8. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00480-2/fulltext?rss=yes

Safety and activity of tarlatamab in combination with a PD ... These studies showed a good benefit–risk profile for tarlatamab in previously-treated small-cell lung cancer (SCLC), leading to global ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307980

Tarlatamab for Patients with Previously Treated Small-Cell ... Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival outcomes