NCT06287775 · National Cancer Institute (NCI)
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
What this study 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 the usual treatment chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell grow
View original scientific description
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.
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
Primary outcome measures
Progression free survival
Time frame: From start of treatment to time of progression or death, whichever occurs first, up to 2 years
Will be estimated using the method of Kaplan and Meier and will be presented with 95% confidence intervals as measure of effect size.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 durvalumab in patients \<18 years of age, children are excluded from this study
- Body weight ≥ 50 kg
- Patient is able to swallow oral medications
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). This assessment for eligibility will take place after patients have received 4 cycles of standard of care (SOC) chemotherapy-ICI
- Leukocytes ≥ 2,000/mcL
Where
- Duarte, California
- Irvine, California
- La Jolla, California
- Sacramento, California
- Hartford, Connecticut
- New Haven, Connecticut
- North Haven, Connecticut
- Stamford, Connecticut
- Trumbull, Connecticut
- Washington D.C., District of Columbia
- Gainesville, Florida
- Tampa, Florida
And 28 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations