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RECRUITING
NCT06287775
PHASE1/PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-04-08

Completion Date

2029-07-25

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

Atezolizumab

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

Durvalumab

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Iadademstat

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Locations (43)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States