Small-cell Lung CancerPhase 1NCT07545954
DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer
A Phase 1 study testing DSP-0390 and Atezolizumab in people with Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Small Cell Lung Cancer Extensive Stage
- What is being tested?
- DSP-0390 and Atezolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 28 Feb 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed small cell lung cancer.
- Completed 3-4 cycles of induction chemoimmunotherapy as first line treatment of ES-SCLC without disease progression.
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Adequate bone marrow and organ function as defined below:
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- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (≤ 5.0 x IULN for patients with liver metastases)
- Calculated creatinine clearance > 40 mL/min by Cockcroft-Gault
- The effects of DSP-0390 on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study treatment, and for 6 months after the last dose of DSP-0390.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial
- Currently receiving any other investigational agents, or received within 4 weeks prior to Day 1 (unless investigational immunotherapy, which may not have been received within 6 weeks prior to Day 1).
- Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases < 5 mm are allowed.
- Known contraindications to use of PD-L1 inhibitor as assessed by the treating physician.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390 or atezolizumab.
- Undergone major surgery within 28 days prior to Cycle 1 Day 1.
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- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.
- Patient is known to have short-gut syndrome, or other condition that may significantly limit the ingestion or gastrointestinal absorption of drugs administered orally.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
- Concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, other strong or moderate CYP3A4 inhibitor or inducer, or strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study day 1. Note that both oral and IV ondansetron at doses ≤ 8 mg Q6h are permitted.
- Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF >450 msec for males and >470 msec for females); and/or the patient has a history of Torsade de Pointes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Ece Cali Daylan, MD, PhD, 314-273-8008, ayseece@wustl.edu
Ece Cali Daylan, MD, PhD
About this study
Official title: A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer
This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with platinum-based chemotherapy and anti-PD-L1 immunotherapy (atezolizumab or durvalumab per treating physician's discretion). This trial is testing the hypothesis that inhibition of de novo cholesterol synthesis by DSP-0390 when used in combination with atezolizumab in the maintenance therapy of patients with ES-SCLC will be tolerable.
- Being tested
- DSP-0390, Atezolizumab
- Keywords
- Small cell, Lipid metabolism, Immunotherapy, Maintenance
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-0390Drug
Patients should take DSP-0390 once a day at approximately the same time every day. DSP-0390 may be taken before or after atezolizumab on days when both drugs are given.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab | Experimental | 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. Receives: Drug: DSP-0390; Drug: Atezolizumab |
| Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab | Experimental | 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. Receives: Drug: DSP-0390; Drug: Atezolizumab |
| Determined safe dose: DSP-0390 + Atezolizumab | Experimental | 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. Receives: Drug: DSP-0390; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Treatment-emergent adverse events will be assessed according to CTCAE v 6.0
Measured: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
Incidence of treatment-related adverse events
Treatment-related adverse events will be assessed according to CTCAE v 6.0
Measured: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
Secondary outcomes (1)
Objective Response Rate (ORR)
ORR is defined as incidence of Partial Response (PR) or Complete Response (CR) assessed by RECIST 1.1 criteria. RECIST 1.1 criteria are outlined below.
Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: To completion of follow-up or first sign of progression, whichever comes first (total estimated time to be 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start3 Aug 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Ece Cali Daylan, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545954
- Sponsor's protocol ID
- 202605187
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07545954
- Acronym / sponsor ID
- 202605187
- Keywords
- Small cell, Lipid metabolism, Immunotherapy, Maintenance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with platinum-based chemotherapy and anti-PD-L1 immunotherapy (atezolizumab or durvalumab per treating physician's discretion). This trial is testing the hypothesis that inhibition of de novo cholesterol synthesis by DSP-0390 when used in combination with atezolizumab in the maintenance therapy of patients with ES-SCLC will be tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab | Experimental | Drug: DSP-0390, Drug: AtezolizumabDSP-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. |
| Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab | Experimental | Drug: DSP-0390, Drug: AtezolizumabDSP-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. |
| Determined safe dose: DSP-0390 + Atezolizumab | Experimental | Drug: DSP-0390, Drug: AtezolizumabDSP-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed small cell lung cancer.
- Completed 3-4 cycles of induction chemoimmunotherapy as first line treatment of ES-SCLC without disease progression.
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 2
Key exclusion criteria (14 listed)
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial
- Currently receiving any other investigational agents, or received within 4 weeks prior to Day 1 (unless investigational immunotherapy, which may not have been received within 6 weeks prior to Day 1).
- Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases < 5 mm are allowed.
- Known contraindications to use of PD-L1 inhibitor as assessed by the treating physician.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390 or atezolizumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP-0390Patients should take DSP-0390 once a day at approximately the same time every day. DSP-0390 may be taken before or after atezolizumab on days when both drugs are given. | Drug | Determined safe dose: DSP-0390 + Atezolizumab, Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab, Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab |
| AtezolizumabAlso: TecentriqAtezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks. | Drug | Determined safe dose: DSP-0390 + Atezolizumab, Safety Lead-In: Dose Level 1 DSP-390 + Atezolizumab, Safety Lead-In: Dose level -1 DSP-390 + Atezolizumab |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
Treatment-emergent adverse events will be assessed according to CTCAE v 6.0
Incidence of treatment-related adverse events
Time frame: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
Treatment-related adverse events will be assessed according to CTCAE v 6.0
1 secondary outcome
Objective Response Rate (ORR)
Time frame: To completion of follow-up or first sign of progression, whichever comes first (total estimated time to be 2.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ece Cali Daylan, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DSP-0390 and Atezolizumab in people with Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Cali Daylan, MD, PhD (314-273-8008, ayseece@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.