Phase 3 Study of Rilvegostomig with Chemotherapy and Trastuzumab Deruxtecan for First-line Treatment of HER2-positive Gastric Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06764875
This clinical trial is testing a new combination of drugs, including Rilvegostomig, for treating HER2-positive gastric cancer that is advanced or has spread. The study compares different drug combinations to see which works best.
Patient Parameters
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Program Overview
This study is testing the effectiveness and safety of a new drug combination for treating HER2-positive gastric cancer that is advanced or has spread. The trial involves three groups: one group receives Rilvegostomig with chemotherapy and Trastuzumab Deruxtecan, another group receives Trastuzumab with chemotherapy and Pembrolizumab, and a third group receives Rilvegostomig with Trastuzumab and chemotherapy. The study aims to find out which combination is most effective in controlling the cancer.
Description
The purpose of this study is to evaluate how well a new drug combination works for treating HER2-positive gastric cancer that is advanced or has spread. The study involves three groups of patients:
- Group A will receive Rilvegostomig with chemotherapy and Trastuzumab Deruxtecan.
- Group B will receive Trastuzumab with chemotherapy and Pembrolizumab.
- Group C will receive Rilvegostomig with Trastuzumab and chemotherapy.
The study will take place at 200-250 locations worldwide in about 25 countries. Researchers will compare the effectiveness and safety of these treatments to determine the best option for patients.
Eligibility Criteria
Inclusion Criteria
- Must have HER2-positive gastric cancer confirmed by a biopsy.
- Tumor must have a PD-L1 score of 1 or higher.
- Must provide a recent tumor sample for testing.
- Cancer must be advanced or have spread and not been treated before.
- Must be in good general health with a performance status of 0 or 1.
- Must have measurable cancer that can be tracked.
- Must have good organ and bone marrow function.
- Heart function must be at least 55%.
- Must have stopped previous treatments for a sufficient time before starting the study.
Exclusion Criteria
- Problems with the upper digestive tract.
- Known deficiency in a specific enzyme (dihydropyrimidine dehydrogenase).
- Cannot take certain drugs like Pembrolizumab or Trastuzumab.
- History of another cancer unless treated and inactive for 3 years.
- Ongoing side effects from previous cancer treatments.
- Untreated or unstable brain or spinal cord issues.
- Uncontrolled infections or recent live vaccines.
- Active hepatitis B or C unless controlled.
- Serious heart or mental health conditions.
- Autoimmune or inflammatory disorders needing ongoing treatment.
- Lung diseases or conditions needing systemic treatment.
- Fluid buildup in the body needing drainage.
- Recent major surgery or injury.
- Use of immunosuppressive medication recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91010 | Duarte | California |
| Research Site | 90089 | Los Angeles | California |
| Research Site | 90404 | Santa Monica | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 30060 | Marietta | Georgia |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 40217 | Louisville | Kentucky |
| Research Site | 20904 | Silver Spring | Maryland |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 49503 | Grand Rapids | Michigan |
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