Actively Recruiting
Iadademstat + SBRT With Atezo in ES-SCLC
Led by Yale University · Updated on 2026-03-27
15
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Iadademstat + SBRT With Atezo in ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Ability to comply with the study protocol.
- Age 18 years or older.
- Body weight of at least 50 kg.
- Histologically documented extensive stage small cell lung cancer previously treated with at least one platinum-containing chemotherapy regimen, with progressive disease or stable disease after treatment.
- Prior immune checkpoint therapy allowed.
- ECOG performance status between 0 and 2.
- At least one tumor lesion suitable for SBRT.
- At least one additional tumor lesion amenable to biopsy.
- Willingness to undergo tumor biopsies before treatment and 2 weeks after SBRT.
- Agreement to provide blood samples for biomarker research.
- Measurable disease by RECIST v1.1 criteria.
- Asymptomatic or treated CNS metastases allowed under specific conditions.
- Prior palliative radiotherapy completed at least one week before study drug.
- Allowed use of anticonvulsants.
- Adherence to reproductive and contraceptive requirements during and after treatment.
You will not qualify if you...
- History of leptomeningeal disease.
- Untreated symptomatic CNS metastases.
- Recent symptomatic brain metastases unless meeting strict conditions.
- Untreated or unstable spinal cord compression.
- Uncontrolled tumor-related pain.
- Symptomatic lesions needing palliative radiotherapy not yet treated.
- Asymptomatic metastatic lesions likely to cause problems without treatment.
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage (indwelling catheters allowed).
- Uncontrolled or symptomatic high calcium levels.
- Active or history of autoimmune or immune deficiency diseases with exceptions.
- History or evidence of certain lung diseases or active pneumonitis.
- Active tuberculosis.
- Significant recent cardiovascular disease or unstable heart conditions.
- Recent major surgery or planned major surgery during study.
- Recent other malignancies with some exceptions.
- Severe recent infections or active uncontrolled infections.
- Recent therapeutic antibiotics except prophylactic use.
- Prior allogeneic stem cell or organ transplant.
- Conditions contraindicating investigational drug use or increasing risk.
- Recent live attenuated vaccines or planned vaccinations during treatment.
- Current antiviral therapy for HBV.
- Recent investigational or systemic anti-cancer treatments.
- Recent immunostimulatory or immunosuppressive treatments with exceptions.
- History of severe allergic reactions to similar drugs.
- Known allergies to study drug components.
- Malabsorption or conditions affecting drug absorption.
- Pregnancy, breastfeeding, or intent to become pregnant during or shortly after treatment.
- Known HIV, HBV, or HCV infection with some exceptions.
- Abnormal laboratory values indicating end-organ damage.
- Uncontrolled high blood pressure.
- Use of specific antidepressants with KDM1A/LSD1 inhibitory activity.
- Incomplete recovery from prior severe adverse events except certain conditions.
- Significant neuropathy evaluated case-by-case.
- History of serious bleeding or hemorrhages.
- Uncontrolled coagulation disorders.
- Refusal or inability to receive blood products.
- History of immune deficiencies or autoimmune diseases excluding some mild or controlled conditions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
C
Carole Ramm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here