DSP-0390 + Atezolizumab for Small Cell Lung Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-In
Evaluation of safety and preliminary efficacy of DSP-0390 in combination with atezolizumab
Treatment
DSP-0390 administered daily with atezolizumab until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after 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
DSP-0390 will be administered at 120 mg orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.
DSP-0390 will be administered as 180 mg orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.
DSP-0390 will be administered at the determined safe dose orally each day of a 21-day cycle. Atezolizumab will be administered per standard of care and dosing is not dictated by this study. Treatment will continue until disease progression or unacceptable toxicity, for a maximum of 2 years.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Sumitomo Pharma America, Inc.
Industry Sponsor
Jatin Shah
Sumitomo Pharma America, Inc.
Chief Medical Officer since 2024
MD from an unspecified institution
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.
3.
oncologynewscentral.com
oncologynewscentral.com/sclc/immunotherapy-combo-fails-to-improve-survival-in-limited-stage-small-cell-lung-cancerImmunotherapy 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 ...
5.
cancernetwork.com
cancernetwork.com/view/atezolizumab-combo-real-world-data-match-clinical-trial-efficacy-in-sclcAtezolizumab 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 ...
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