Iadademstat + SBRT With Atezo in ES-SCLC (NCT07113691) | Clinical Trial Compass
RecruitingPhase 1
Iadademstat + SBRT With Atezo in ES-SCLC
United States15 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form.
. Ability to comply with protocol, in the treating investigator's judgment.
. Age 18 years or older.
. Participant must have a body weight of at least 50 Kg.
. Histologically documented ES-SCLC previously treated with at least one regimen, including a platinum containing chemotherapy regimen, with progression of disease on or after their most recent therapy or achieving only SD after completion of one line of a platinum containing chemotherapy-based regimen.
. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, antiPD-1, and anti-PD-L1 therapeutic antibodies is allowed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
2
Rate of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
3
Grade of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
4
Frequency of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
5
Rate of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
6
Grade of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
. At least one identified tumor lesion to be treated with SBRT.
Exclusion criteria
. History of leptomeningeal disease.
. Untreated symptomatic CNS metastases. Participants with asymptomatic CNS metastases are eligible. Participant with treated symptomatic brain metastases is eligible provided they meet all of the following criteria:
. Completed stereotactic radiosurgery at least seven days prior to Cycle 1, Day 1 or completed whole brain radiation at least two weeks prior to Cycle 1, Day 1.
. No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy.
. Ongoing steroid requirement of \<10 mg of prednisone per day (or equivalent) as therapy for CNS disease; anticonvulsants are allowed.
. The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than or equal to 1 week prior to enrollment.
. Uncontrolled tumor-related pain.
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long