RecruitingPhase 1NCT07113691

Iadademstat + SBRT With Atezo in ES-SCLC

Iadademstat and Radiation Therapy With Atezolizumab in Extensive Stage Small-cell Lung Cancer (ES-SCLC) Patients With Persistent, Recurrent or Progressive Disease After First Line Systemic Therapy


Sponsor

Yale University

Enrollment

15 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination of three treatments — a drug called iadademstat, targeted radiation (SBRT), and an immunotherapy drug (atezolizumab) — for people with advanced small cell lung cancer (SCLC) that has spread and come back after prior chemotherapy. **You may be eligible if...** - You are 18 or older and weigh at least 50 kg (110 lbs) - You have been diagnosed with extensive-stage small cell lung cancer - Your cancer progressed during or after platinum-based chemotherapy - You have at least one tumor that can be treated with targeted radiation and another that can be biopsied - You are reasonably functional day-to-day (ECOG score 0–2) - You are willing to undergo tumor biopsies before and after treatment **You may NOT be eligible if...** - You have cancer that has spread to the lining of the brain (leptomeningeal disease) - You have uncontrolled brain metastases or currently need steroids for brain cancer - You have uncontrolled pain, fluid buildup around lungs or heart, or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIadademstat

Iadademstat is administered orally (PO) on an empty stomach (two hours after eating or one hour prior to food ingestion). After drinking the entire solution, the participant will be asked to refill the bottle with water and drink it again. Then they will drink another glass of water to wash their mouth and esophagus. Time of administration of the drug should be the same every day, preferentially in the mornings, and the time should be registered using the Dosing Instructions and Participant Drug Diary. If a dose is missed, the dose should be administered as soon as possible within 24 hours of the missed dose time. If more than 24 hours have passed, or a dose is vomited, the participant should call their medical team for instructions.

DRUGAtezolizumab

Atezolizumab will be administered by IV infusion at a fixed dose of 1680mg on Day 1 (+/-3 days) of each 28-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the treating investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Administration of atezolizumab will be performed in a monitored setting where there is immediate access to trained personnel and adequate equipment and medicine to manage potentially serious reactions.

RADIATIONSBRT

The first fraction of SBRT should be delivered after the initiation of iadademstat and atezolizumab, ideally between Cycle 1, Day 8, and Cycle 1, Day 15. Initiation of SBRT may be delayed up to 14 days beyond Cycle 1, Day 15 if iadademstat dose adjustment is required for toxicity


Locations(1)

Yale University

New Haven, Connecticut, United States

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NCT07113691


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