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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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 will be given per standard of care. FDA-approved dosing is 1200 mg intravenously (IV) every three weeks.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGIncidence 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)
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)
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)
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