Study Comparing BMS-986489 (Atigotatug + Nivolumab) and Durvalumab for Limited-stage Small-cell Lung Cancer
Sponsor: SCRI Development Innovations, LLC
ClinicalTrials ID:NCT06773910
This clinical trial is testing two different treatments, BMS-986489 (a combination of atigotatug and nivolumab) and durvalumab, to see which is more effective and safe for patients with limited-stage small-cell lung cancer (LS-SCLC).
Patient Parameters
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Program Overview
The study aims to compare the effectiveness and safety of two treatments for patients with limited-stage small-cell lung cancer (LS-SCLC). Participants will receive either BMS-986489, which combines atigotatug and nivolumab, or durvalumab after completing standard chemotherapy and radiation therapy. Atigotatug is a new type of antibody that targets cancer cells, and nivolumab is an immunotherapy drug. The combination may enhance the body's ability to fight cancer.
Description
This study involves patients with limited-stage small-cell lung cancer (LS-SCLC) who have completed chemotherapy and radiation therapy. Participants will be randomly assigned to receive either BMS-986489 (a combination of atigotatug and nivolumab) or durvalumab as a follow-up treatment. Atigotatug is a new antibody that targets specific markers on cancer cells, while nivolumab is an immunotherapy drug that helps the immune system attack cancer. The study will evaluate how well these treatments work and their safety profiles.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old.
- Have a good performance status, meaning you are fully active or have some restrictions but can still do light work.
- Have a confirmed diagnosis of small-cell lung cancer (SCLC) that is limited to one area.
- Completed chemotherapy and radiation therapy for limited-stage SCLC without the cancer getting worse.
- Have adequate blood and organ function.
- Agree to use effective birth control during the study.
Exclusion Criteria
- Have small-cell cancer that did not start in the lungs.
- Have a different type of lung cancer or a mix of small-cell and non-small-cell lung cancer.
- Have a history of severe allergic reactions to similar treatments.
- Have active autoimmune diseases or require high doses of steroids or other immune-suppressing drugs.
- Have had a solid organ or bone marrow transplant.
- Have significant heart problems or uncontrolled high blood pressure.
- Have other active cancers, unless they were treated and resolved over two years ago.
- Have received certain cancer treatments or vaccines recently.
- Have unresolved side effects from previous treatments, except for hair loss.
- Have conditions that would prevent following the study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sansum Clinic | 93105 | Santa Barbara | California |
| Cancer Care Centers of Brevard | 32901 | Palm Bay | Florida |
| Illinois Cancer Specialists | 60005 | Arlington Heights | Illinois |
| Minnesota Oncology Hematology | 55369 | Maple Grove | Minnesota |
| Oncology Hematology Care | 45242 | Cincinnati | Ohio |
| Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center | 43219 | Columbus | Ohio |
| Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center) | 97401 | Eugene | Oregon |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - West Texas | 79124 | Amarillo | Texas |
| Texas Oncology - Gulf Coast | 77702 | Beaumont | Texas |
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