This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer.
Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC)
Patients who have been treated with platinum etoposide chemotherapy plus either atezolizumab or durvalumab immunotherapy for at least 4 cycles, and no more than 6 cycles, with either a radiographic response or stable disease. Patients are eligible if a maximum of 2 cycles of atezolizumab or durvalumab were omitted with initial treatment
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of iadademstat in combination with atezolizumab and durvalumab in patients <18 years of age, children are excluded from this study
Body weight ≥ 50 kg
Patients who receive maintenance ICI therapy prior to cycle 1, day 1
Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: Tranylcypromine or phenelzine
Patients who have not recovered from grade ≥2 adverse events (AEs) due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
Sequential
Atezolizumab
Biological/VaccineGiven IV
Biopsy Procedure
Procedure/SurgeryUndergo optional tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Durvalumab
Biological/VaccineGiven IV
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Iadademstat
DrugGiven PO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Multigated Acquisition Scan
Procedure/SurgeryUndergo MUGA
Progression free survival
Will be estimated using the method of Kaplan and Meier and will be presented with 95% confidence intervals as measure of effect size.
Objective response rate
Overall survival
Will be estimated using the method of Kaplan and Meier and will be presented with 95% confidence intervals as measure of effect size.
Incidence of adverse events
Detection of circulating tumor deoxyribonucleic acid minimal residual disease
Impact of iadademstat on the correlation of immune checkpoint inhibitors (ICIs) and the presence of cachexia
Exposure response relationships of iadademstat in combination with ICIs
Changes to small cell lung cancer subtype
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