DSP-0390 with Atezolizumab for Small Cell Lung Cancer
This study is testing a new combination treatment for extensive stage small cell lung cancer (ES-SCLC). It combines DSP-0390 with atezolizumab (an immunotherapy drug that works by targeting PD-L1). Researchers want to see if this combination is safe and tolerable for patients whose cancer has not worsened after initial chemotherapy and immunotherapy. You may be able to join if you have ES-SCLC that has not progressed after initial treatment, are at least 18 years old, and meet other health requirements. The study is primarily looking at side effects. This is a small, single-center study with 20 planned participants, and its current recruitment status is unclear.
- Study design
- This is a small, single-center pilot study (Phase Ib) with 20 planned participants. It is evaluating the safety and early effectiveness of the drug combination.
- What's involved
- You would take DSP-0390 once daily and receive atezolizumab intravenously every three weeks. The specific schedule of visits and tests is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for side effects until 30 days after completing treatment, which is estimated to be about 2 years and 30 days.
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NCT07545954
DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~20 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:DSP-0390Atezolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Ece Cali Daylan, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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.
Exclusion
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.
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.
What this trial measures
- Incidence of treatment-emergent adverse eventsUntil 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 eventsUntil 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