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DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer

ConditionsSmall-cell Lung CancerSmall Cell Lung Cancer Extensive Stage
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DSP-0390

    Drug

    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.

  • Atezolizumab

    Drug

    Atezolizumab will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Safety Lead-In: Dose Level 1 DSP-390 + AtezolizumabExperimental treatment 2 interventions
Group B: Safety Lead-In: Dose level -1 DSP-390 + AtezolizumabExperimental treatment 2 interventions
Group C: Determined safe dose: DSP-0390 + AtezolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events

Treatment-emergent adverse events will be assessed according to CTCAE v 6.0

Time frame
Until 30 days after completion of treatment (estimated time to be 2 years and 30 days)
2

Incidence of treatment-related adverse events

Treatment-related adverse events will be assessed according to CTCAE v 6.0

Time frame
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.

Time frame
To completion of follow-up or first sign of progression, whichever comes first (total estimated time to be 2.5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Sumitomo Pharma America, Inc.

Collaborator

Source ClinicalTrials.gov
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