Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
45
Participants Needed
43
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 for 4 to 6 cycles with response or stable disease
- Age 18 years or older
- Body weight at least 50 kg
- Ability to swallow oral medications
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky 60% or higher)
- Leukocyte count at least 2,000/mcL
- Lymphocyte count at least 500/mcL
- Absolute neutrophil count at least 1,500/mcL
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mcL
- Albumin at least 3 g/dL
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN)
- AST/ALT less than or equal to 3 times ULN unless liver metastases present, then less than or equal to 5 times ULN
- Glomerular filtration rate at least 45 mL/min
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy
- Patients with hepatitis C must be treated and cured or have undetectable viral load if currently on treatment
- Patients with treated brain metastases or asymptomatic untreated brain metastases 5 mm or smaller without significant edema are eligible
- Patients with prior or concurrent malignancy not interfering with study safety or efficacy
- Women must be post-menopausal or have negative pregnancy test if pre-menopausal
- Women and males with females of childbearing potential must agree to use contraception during and for 150 days after study
- Breastfeeding women must agree to discontinue breastfeeding
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Patients receiving maintenance immune checkpoint inhibitor (ICI) therapy before cycle 1, day 1
- Use of anti-depressants with KDM1A/LSD1 inhibitory activity such as tranylcypromine or phenelzine
- Not recovered from grade 2 or higher adverse events from prior cancer therapy except alopecia, vitiligo, and lab abnormalities defined in inclusion
- Grade 2 or higher neuropathy unless approved after physician consultation
- Receiving other investigational agents or cancer treatments within 4 weeks or 4 half-lives before registration
- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives before cycle 1, day 1
- Treatment with systemic immunosuppressive medications within 2 weeks before registration except certain low-dose or chronic corticosteroids
- History of allergic reactions to iadademstat, atezolizumab, durvalumab, or similar compounds
- Use of immunostimulatory agents, immunosuppressive medications, or herbal remedies contraindicated with study drugs
- History of allogenic organ transplantation
- Active tuberculosis
- Uncontrolled illness or conditions making study participation unsafe
- History of certain lung conditions including idiopathic pulmonary fibrosis or active pneumonitis
- Recent unstable angina, uncontrolled arrhythmia, recent myocardial infarction or stroke, or significant congestive heart failure
- History or risk of autoimmune diseases except controlled hypothyroidism, type 1 diabetes, certain skin conditions, celiac disease, or inactive disease after consultation
- Vaccination with live attenuated vaccines within 30 days before first dose
- Major surgery or radiation therapy within 4 weeks before registration except palliative or CNS radiation
- Gastrointestinal conditions affecting absorption of iadademstat
- History of clinically significant bleeding or bleeding disorders
- Refusal or inability to receive blood products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
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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