National Cancer Institute (NCI)
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.
PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) between the combination of iadademstat plus immune checkpoint inhibitor (ICI) versus ICI maintenance alone. SECONDARY OBJECTIVES: I. To compare objective response rate (ORR) and overall survival (OS) between treatment arms. II. To evaluate the safety of combination iadademstat plus ICI. EXPLORATORY OBJECTIVES: I. To assess whether detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) minimal residual disease correlates with disease progression. II. To assess whether iadademstat impacts the correlation of I…
Inclusion Criteria: * 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…
Given IV
Undergo optional tumor biopsy
Undergo blood and urine sample collection
Undergo CT scan
Given IV
Undergo ECHO
Given PO
Undergo MRI
Undergo MUGA