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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (34 items) and avoid the listed exclusions (37 items).
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who receive maintenance ICI therapy prior to cycle 1, day 1
- Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: Tranylcypromine or phenelzine
- Patients who have not recovered from grade ≥2 adverse events (AEs) due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
- Patients who are receiving any other investigational agents or any other agent administered for the treatment of the patient's cancer within four half-lives or 4 weeks prior to registration, whichever is shorter
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \[IFN\]-α or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1
- Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- Patients who have received acute, low dose, systemic immunosuppressant medications or one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible after Principal Investigator confirmation has been obtained.
- Patients who have received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenocortical insufficiency are eligible
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to iadademstat, atezolizumab, or durvalumab. In particular, a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- Atezolizumab Concomitant Medication Considerations: Patients are not allowed to receive immunostimulatory agents, immunosuppressive medications, or herbal and natural remedies
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- City of Hope Comprehensive Cancer Center — Duarte, California
- City of Hope at Irvine Lennar — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
- Yale University — New Haven, Connecticut
- Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Moffitt Cancer Center — Tampa, Florida
- Emory University Hospital Midtown — Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Emory Saint Joseph's Hospital — Atlanta, Georgia
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois
- University of Chicago Medicine-Orland Park — Orland Park, Illinois
- UChicago Medicine Northwest Indiana — Crown Point, Indiana
- University of Kansas Clinical Research Center — Fairway, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas
- University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Email: becomingapatient@coh.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Extensive Stage Lung Small Cell Carcinoma
- Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer — Buffalo, New York
- LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer — Duarte, California
- Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker — Anchorage, Alaska
- Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial — Houston, Texas
- S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer — Birmingham, Alabama
Explore by condition: All Extensive Stage Lung Small Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.