Iadademstat + SBRT With Atezo in ES-SCLC (NCT07113691)

🧪 Interventions in This Study

• Iadademstat (DRUG)
• Atezolizumab (DRUG)

Check 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).

1. Signed informed consent form.
2. Ability to comply with protocol, in the treating investigator's judgment.
3. Age 18 years or older.
4. Participant must have a body weight of at least 50 Kg.
5. 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. a. Participants previously diagnosed with limited stage SCLC treated with concurrent chemoradiation with a platinum doublet now diagnosed with recurrent extensive disease in the relapsed setting are eligible.
6. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, antiPD-1, and anti-PD-L1 therapeutic antibodies is allowed.
7. ECOG performance status of 0 to 2.
8. At least one identified tumor lesion to be treated with SBRT.
9. At least one additional tumor lesion, separate from the site of SBRT, preferably outside of the 5Gy isodose line, amenable to incisional, excisional, core or forceps (transbronchial) biopsy. Participants must be willing to undergo tumor biopsies before starting trial therapy and 2 weeks (+/- 1 week) after the completion of SBRT.
10. If the initial biopsy is excisional, the excised tumor cannot be counted as a biopsy target lesion and there must be another lesion amenable to incisional, excisional, core or forceps biopsy. In this scenario, the second biopsy can only be excisional if the lesion to be excised is not a target lesion.
11. Cytology tumor specimens (e.g., from fine-needle biopsies, or drainage of pleural/ pericardial or ascites fluid) are not acceptable. Biopsies of bone lesions that do not have a soft tissue component are also not acceptable (i.e., decalcified tumor samples are not acceptable). Non-lymph node sites will be biopsied preferentially.
12. If enrolled with stable, but not progressive, disease at the completion of first line platinum-based therapy regimen, participants may undergo biopsy of the same site that is to be irradiated. If a separate site is identified for biopsy, it should be preferentially biopsied over the site that is to be irradiated.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Yale University — New Haven, Connecticut

📞 Contact the Study Coordinator

Phone: (203) 737-5801

Email: carole.ramm@yale.edu

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.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.