Study Comparing Pumitamig and Durvalumab After Chemoradiation in Patients with Unremovable Stage III Non-small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07361497
This clinical trial is testing two different treatments, Pumitamig and Durvalumab, to see which is more effective after patients with Stage III Non-small Cell Lung Cancer have received chemoradiation therapy. The study focuses on patients whose cancer cannot be removed by surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness of two treatments, Pumitamig and Durvalumab, in patients with Stage III Non-small Cell Lung Cancer (NSCLC) that cannot be surgically removed. Participants will receive one of these treatments after completing a combination of chemotherapy and radiation therapy to see which treatment better controls the cancer.
Eligibility Criteria
Inclusion Criteria
- Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
- Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
- Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Exclusion Criteria
- Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
- Participants must not have an active autoimmune disease.
- Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
- Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
- Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Southern Cancer Center Pc | 36526 | Daphne | Alabama |
| Local Institution - 0780 | 85224 | Chandler | Arizona |
| Local Institution - 0585 | 80401 | Golden | Colorado |
| Medical Oncology Hematology Consultants, PA | 19713 | Newark | Delaware |
| Local Institution - 0711 | 34474 | Ocala | Florida |
| Local Institution - 0756 | 30060 | Marietta | Georgia |
| Local Institution - 0398 | 60637 | Chicago | Illinois |
| Local Institution - 0850 | 60201 | Evanston | Illinois |
| Illinois Cancer Care | 61615 | Peoria | Illinois |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
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