Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer
NCT06287775 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-22
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.
Conditions
- Extensive Stage Lung Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
Interventions
- PROCEDURE
-
Multigated Acquisition Scan
Undergo MUGA
- DRUG
-
Iadademstat
Given PO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biopsy Procedure
Undergo optional tumor biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo blood and urine sample collection
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Charles M Rudin · JHU Sidney Kimmel Comprehensive Cancer Center LAO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-08
- Primary Completion
- 2029-07-25
- Completion
- 2029-07-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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