A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
National Cancer Institute (NCI)
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalAtezolizumab
Given IV
- ProcedureBiopsy Procedure
Undergo optional tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- BiologicalDurvalumab
Given IV
- ProcedureEchocardiography Test
Undergo ECHO
- DrugIadademstat
Given PO
Locations (43)
- City of Hope Comprehensive Cancer CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- Smilow Cancer Hospital Care Center at Saint FrancisHartford, Connecticut
- Yale UniversityNew Haven, Connecticut