Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-22
45
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of iadademstat combined with either atezolizumab or durvalumab for patients with extensive-stage small cell lung cancer that has spread beyond the lung. This trial includes patients who initially received standard chemotherapy and immunotherapy. The goal is to see if adding iadademstat can help control the cancer longer compared to immunotherapy alone. The study also explores various biological markers and the effects of the treatments on cancer subtypes and patient outcomes. The study has two parts: Phase I and Phase II. In Phase I, patients receive iadademstat by mouth on specific days of each 28-day cycle along with their ongoing immunotherapy (atezolizumab or durvalumab) given intravenously on day 1 of each cycle. In Phase II, patients are randomly assigned to either continue their immunotherapy alone or receive iadademstat plus immunotherapy on the same schedule. Treatment continues until the cancer worsens or side effects become unacceptable. Participants will undergo various scans including heart function tests (MUGA or echocardiogram), brain imaging (MRI or CT), and CT scans throughout the trial. Blood and urine samples will be collected regularly and optional tumor biopsies may be performed. Following treatment, patients will be monitored every three months for up to one year. Researchers will measure how long patients live without cancer progression as the main outcome and will also assess response rates, overall survival, and safety of the treatments.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC)
- Patients treated with platinum etoposide chemotherapy plus atezolizumab or durvalumab immunotherapy for 4 to 6 cycles, with radiographic response or stable disease
- A maximum of 2 cycles of atezolizumab or durvalumab may have been omitted during initial treatment
- Age 18 years or older
- Body weight 50 kg or greater
- Able to swallow oral medications
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky score 60% or higher)
- Leukocytes 2,000/mcL or greater
- Lymphocyte count 500/mcL or greater
- Absolute neutrophil count 1,500/mcL or greater
- Hemoglobin 9 g/dL or greater
- Platelets 100,000/mcL or greater
- Albumin 3 g/dL or greater
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN)
- AST and ALT less than or equal to 3 times ULN unless liver metastases are present (then up to 5 times ULN)
- Glomerular filtration rate 45 mL/min or greater
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- Patients with controlled or cured hepatitis B or C virus infection
- Patients with treated or stable brain metastases meeting specified criteria
- Patients with prior or concurrent malignancies unlikely to interfere with study
- Females must be post-menopausal or have negative pregnancy tests, and agree to contraception requirements
- Male patients must agree to contraception requirements
- Female participants who are breastfeeding must agree to discontinue breastfeeding
- Ability to understand and sign informed consent
You will not qualify if you...
- Patients who received maintenance immune checkpoint inhibitor therapy before study start
- Patients taking antidepressants known to inhibit KDM1A/LSD1 activity (e.g., tranylcypromine, phenelzine)
- Patients not recovered from grade 2 or higher adverse events from prior cancer therapy (except alopecia, vitiligo, and certain lab values)
- Patients currently receiving other investigational or cancer treatments within 4 weeks prior to registration
- Patients treated with systemic immunostimulatory or immunosuppressive agents within specified time frames before study
- History of allergic reactions to similar compounds or study drugs
- Patients receiving prohibited medications or complementary/alternative medicine near study start
- History of allogenic organ transplantation
- Active tuberculosis infection
- Uncontrolled illness or conditions posing risk during study
- History or evidence of significant lung inflammation or pneumonitis except stable radiation-induced changes
- Unstable angina, uncontrolled arrhythmia, recent heart attack or stroke, or certain heart failure conditions
- History or risk of autoimmune diseases except specified controlled cases
- Patients recently vaccinated with live vaccines or planned vaccination during study except certain exceptions
- Major surgery or radiation therapy within 4 weeks prior to registration
- Malabsorption conditions affecting drug absorption
- History of significant bleeding disorders or recent bleeding events
- Patients unable or unwilling to receive blood products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive iadademstat orally on specified days of each 28-day cycle and continue receiving immune checkpoint inhibitors (atezolizumab or durvalumab) intravenously on day 1 of each cycle. This continues in the absence of disease progression or unacceptable toxicity. Participants also undergo CT scans and blood and urine sample collection throughout treatment. An optional tumor biopsy may be performed during treatment.
Visits on days 1, 8, 15, and 22 or days 1 and 15 of each 28-day cycle depending on iadademstat schedule; infusions on day 1 of each cycle
Duration - Up to 12 months
After completion of study treatment, participants are followed up every 3 months to monitor health and outcomes.
Visits every 3 months for up to 12 months
Trial Site Locations
Total: 43 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
5
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Suspended
6
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
8
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Suspended
9
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
10
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
11
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
12
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Suspended
13
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
14
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
16
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
17
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
18
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
19
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
20
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
21
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
22
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
23
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
24
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
25
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
26
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
27
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
28
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
29
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
30
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
31
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
32
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
33
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
34
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
35
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Actively Recruiting
36
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
37
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Suspended
38
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
39
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
40
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Suspended
41
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
42
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
43
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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