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

Trial Summary

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 data supports the effectiveness of the drug Tarlatamab for small cell lung cancer?

Research indicates that Tarlatamab, a drug designed to engage the body's immune cells to target cancer cells, has shown promising results in patients with small cell lung cancer who have not responded to other treatments. ^{1 2 3 4 5}

What safety data exists for Tarlatamab in humans?

Tarlatamab has shown promising activity in patients with small cell lung cancer, but there are questions about its challenging administration, which may affect its use by clinicians and patients. ^{1 2 6 7 8}

How is the drug Tarlatamab different from other treatments for small cell lung cancer?

Tarlatamab is unique because it is a bispecific T-cell engager that targets a protein called delta-like ligand 3 (DLL3), which is often found in small cell lung cancer. This drug works by binding to both DLL3 on cancer cells and CD3 on T-cells, helping the immune system to attack the cancer. ^{1 6 9 10 11}

What is the purpose of this trial?

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).

Research Team

Robert Daly, MD, MBA

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Participants randomized to the Hospital-at-Home/HAH arm will have regular home visits by a SeniorCare community paramedic.

Group II: Control Arm Active Control 1 Intervention

Participants randomized to the control group will receive administration of tarlatamab and subsequent inpatient monitoring according to MSK SOP

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tarlatamab Shows Promise in SCLC. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled, Phase 1b/2 Study of Rilotumumab or Ganitumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Trends, predictors, and impact of systemic chemotherapy in small cell lung cancer patients between 1985 and 2005. [2018]

5. United States 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. [2023]

6. England 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. [2023]

7. Singapore pubmed.ncbi.nlm.nih.gov

Relationship between immune-related adverse events and treatment effectiveness in extensive disease small cell lung cancer. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Safety of topotecan monotherapy for relapsed small cell lung cancer patients with pre-existing interstitial lung disease. [2015]

9. United States 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. [2023]

10. China pubmed.ncbi.nlm.nih.gov

[Clinical Progress in the Immunotherapy of Small Cell Lung Cancer]. [2022]

11. Ireland 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. [2023]