Study on Combining Iadademstat with Atezolizumab or Durvalumab to Improve Outcomes for Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06287775
This clinical trial is testing a new treatment that combines the drug iadademstat with either atezolizumab or durvalumab to see if it can improve outcomes for patients with small cell lung cancer that has spread beyond the lungs. The study aims to find the safest and most effective dose of iadademstat when used with these immunotherapy drugs.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding the drug iadademstat to the immunotherapy drugs atezolizumab or durvalumab can help control small cell lung cancer that has spread outside the lungs. Iadademstat may help stop cancer cells from growing by blocking certain enzymes, while atezolizumab and durvalumab help the immune system attack cancer cells. The study will test the safety, side effects, and best dose of this combination treatment.
Description
This study is divided into two phases: Phase I and Phase II.
In Phase I, researchers will test different doses of iadademstat to find the safest and most effective dose when combined with either atezolizumab or durvalumab. Patients will take iadademstat by mouth on specific days of each treatment cycle, while continuing their immunotherapy treatment through an IV. Each cycle lasts 28 days, and treatment continues as long as the cancer does not progress and side effects are manageable.
In Phase II, patients will be randomly assigned to one of two groups. One group will receive the combination of iadademstat and their initial immunotherapy treatment, while the other group will continue with their initial immunotherapy treatment alone. The goal is to compare how well the cancer is controlled in each group.
Throughout the study, patients will undergo various tests, including heart and brain scans, and provide blood and urine samples. An optional tumor biopsy may also be performed. After completing the study treatment, patients will have follow-up visits every three months for up to a year.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with small cell lung cancer that can be measured by scans or exams.
- Cancer has spread beyond the lungs and has been treated with chemotherapy and immunotherapy.
- Aged 18 years or older.
- Weigh at least 50 kg.
- Able to swallow pills.
- In good general health, with specific blood counts and organ function within normal limits.
- Women must not be pregnant and must agree to use effective birth control during the study and for 150 days after the last treatment.
- Men must agree to use effective birth control during the study and for 150 days after the last treatment.
- Able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Taking certain antidepressants that may interfere with the study drugs.
- Have not recovered from significant side effects of previous cancer treatments.
- Currently receiving other investigational drugs or treatments for cancer.
- Have a history of severe allergic reactions to similar drugs.
- Have active infections like tuberculosis or uncontrolled illnesses.
- Have certain lung or heart conditions that are not well-controlled.
- Have a history of autoimmune diseases, unless well-controlled.
- Have had major surgery or radiation therapy recently.
- Have conditions that affect the absorption of oral medications.
- Have a history of significant bleeding disorders or are on blood thinners.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Florida Health Science Center - Gainesville | 32610 | Gainesville | Florida |
| University of Kentucky/Markey Cancer Center | 40536 | Lexington | Kentucky |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
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