20 Participants NeededMy employer runs this trial

DSP-0390 + Atezolizumab for Small Cell Lung Cancer

EC
Overseen ByEce Cali Daylan, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for individuals with extensive stage small cell lung cancer (ES-SCLC). Researchers aim to determine if adding DSP-0390, an experimental drug, to the existing treatment atezolizumab, an immune therapy, is safe and effective in controlling the cancer. The trial targets those whose cancer has not worsened after initial chemotherapy with immune therapy. Ideal participants have confirmed small cell lung cancer and have completed several cycles of initial treatment without cancer progression. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, especially if they are strong or moderate CYP3A4 or CYP2D6 inhibitors or inducers. These should be discontinued at least 1 week or 5 half-lives before starting the trial. Always discuss with your doctor to ensure safety.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In other studies, atezolizumab has generally been safe. About 27.7% of patients experienced immune-related side effects like skin rash or diarrhea. Severe cases occurred in 9.9% of patients, and very severe cases in about 2.1%. This indicates that most people tolerate the treatment well.

Regarding DSP-0390, limited public information exists because it remains in early testing. The current study is in Phase 1, focusing on assessing the treatment's safety for humans. Scientists continue to learn about possible side effects.

Combining DSP-0390 with atezolizumab is new, so the study will closely monitor for side effects. Specific safety data for this combination is not yet available. However, atezolizumab's safety record provides some reassurance about what to expect.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about DSP-0390 combined with Atezolizumab for treating small cell lung cancer because DSP-0390 introduces a new approach with its oral administration, making it potentially more convenient for patients than traditional intravenous chemotherapy. While most current treatments focus on targeting cancer cells directly, DSP-0390's unique mechanism might offer a different pathway to attack the cancer, potentially leading to better outcomes. Additionally, combining it with Atezolizumab, an immune checkpoint inhibitor, may enhance the body's immune response against the cancer, offering hope for improved effectiveness compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that atezolizumab effectively treats extensive-stage small cell lung cancer (ES-SCLC). Studies have found that patients receiving atezolizumab with chemotherapy tend to live longer, with an average survival time of about 16.5 months in real-world situations. This trial investigates DSP-0390 for its potential to block cholesterol production, which might enhance treatment outcomes when combined with atezolizumab. Although information on DSP-0390 remains limited, combining it with atezolizumab appears promising based on these effects. Participants in this trial will receive varying doses of DSP-0390 alongside atezolizumab to determine the safest and most effective combination.15678

Who Is on the Research Team?

EC

Ece Cali Daylan, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with extensive stage small cell lung cancer whose disease has not worsened after initial chemo and immunotherapy. Participants must have good organ function, be able to consent, use contraception if needed, and cannot join if they have certain infections, heart issues, or allergies to the study drugs.

Inclusion Criteria

Measurable disease per RECIST 1.1
Agree to use adequate contraception if of childbearing potential or able to father a child
I understand the study and am willing to sign a consent form.
See 5 more

Exclusion Criteria

History of allergic reactions to compounds of similar composition to DSP-0390 or atezolizumab
I do not have another cancer that could affect this study's results.
I have a known reason why I cannot take PD-L1 inhibitor medication.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Evaluation of safety and preliminary efficacy of DSP-0390 in combination with atezolizumab

21-day cycles, up to 2 years
Regular visits per 21-day cycle

Treatment

DSP-0390 administered daily with atezolizumab until disease progression or unacceptable toxicity

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • DSP-0390

Trial Overview

The study tests a new drug called DSP-0390 combined with atezolizumab as maintenance therapy for small cell lung cancer. It aims to see if this combination is safe and possibly effective in patients who responded well to first-line treatment.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Safety Lead-In: Dose level -1 DSP-390 + AtezolizumabExperimental Treatment2 Interventions
Group II: Safety Lead-In: Dose Level 1 DSP-390 + AtezolizumabExperimental Treatment2 Interventions
Group III: Determined safe dose: DSP-0390 + AtezolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Sumitomo Pharma America, Inc.

Industry Sponsor

Trials
244
Recruited
51,500+
Jatin Shah profile image

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa profile image

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Citations

DSP-0390 in Combination With Atezolizumab for Small ...

This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor ...

Effectiveness of Atezolizumab in Addition to Chemotherapy in ...

Atezolizumab showed effectiveness and manageable safety consistent with clinical trials, supporting its use in routine ES-SCLC treatment.

Immunotherapy Combo Fails to Improve Survival in Limited ...

Adding atezolizumab to concurrent chemoradiation did not improve survival for patients with limited-stage small cell lung cancer, ...

Atezolizumab for Alveolar Soft Part Sarcoma: A Clinical ...

Fifty-three patients with ASPS received atezolizumab. Median duration of response increased to 37.0 months. Objective response rate (ORR) and ...

Atezolizumab Combo Real-World Data Match Clinical Trial ...

In the overall efficacy population, the median overall survival (OS) was 16.5 months (95% CI, 14.9-18.2), and the 12-month OS rate was 63.7% (95 ...

DSP-0390 + Atezolizumab for Small Cell Lung Cancer

Safety Lead-In. Evaluation of safety and preliminary efficacy of DSP-0390 in combination with atezolizumab. 21-day cycles, up to 2 years.

Efficacy and safety of atezolizumab, in combination with ... - PMC

The study provides real-world data of Korean small-cell lung cancer patients showing comparable outcomes with IMpower133 study, in which Asians were ...

DSP-0390 in Combination With Atezolizumab for Small ...

Incidence of treatment-emergent adverse events, Treatment-emergent adverse events will be assessed according to CTCAE v 6.0, Until 30 days after completion of ...