Phase III Study of Dato-DXd and Rilvegostomig for Stage I Adenocarcinoma NSCLC After Tumor Removal
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06564844
This study is testing a new treatment using Dato-DXd and Rilvegostomig, either together or alone, compared to the usual care for patients with Stage I adenocarcinoma non-small cell lung cancer (NSCLC) who have had their tumors completely removed and are at high risk of cancer returning.
Patient Parameters
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Program Overview
The study aims to find out if the combination of Dato-DXd and Rilvegostomig, or Rilvegostomig alone, is more effective and safe compared to the standard treatment for patients with Stage I adenocarcinoma NSCLC. This is for patients who have had their tumors completely removed and are either positive for circulating tumor DNA (ctDNA) or have high-risk features that could lead to cancer returning.
Description
The main goal of this study is to see if using Dato-DXd with Rilvegostomig, or Rilvegostomig by itself, is better than the usual treatment for patients with Stage I adenocarcinoma NSCLC. This is for those who have had their tumors completely removed and are at risk of cancer coming back, either because they have ctDNA in their blood or certain high-risk features. The study will look at how well the treatment works and how safe it is for these patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage I adenocarcinoma NSCLC, with a tumor smaller than 4 cm.
- Have had a complete surgical removal of the lung cancer.
- No signs of cancer after surgery.
- Either have ctDNA in the blood before surgery or have high-risk features like certain types of tissue invasion or high-grade cancer cells.
- Be in good general health with a performance status of 0 or 1 and a life expectancy of more than 6 months.
- Have good bone marrow and organ function.
Exclusion Criteria
- Have specific genetic changes in the cancer, like EGFR mutations or ALK alterations.
- Have a history of lung inflammation that needed steroids or have current lung inflammation.
- Have significant lung function problems.
- Have had another cancer within the last 3 years, with some exceptions.
- Have severe or uncontrolled diseases, including bleeding disorders, active infections, or heart disease.
- Have active or past autoimmune or inflammatory disorders, with some exceptions.
- Have active infections like tuberculosis, hepatitis B or C, hepatitis A, or uncontrolled HIV.
- Have a history of immune system problems.
- Have significant eye disease affecting the cornea.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 85710 | Tucson | Arizona |
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 91010 | Duarte | California |
| Research Site | 92708 | Fountain Valley | California |
| Research Site | 91204 | Glendale | California |
| Research Site | 90033 | Los Angeles | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
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