Global Study on Rilvegostomig or Pembrolizumab for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06868277
This international clinical trial is comparing two treatments, rilvegostomig and pembrolizumab, to see which is more effective and safe for patients with advanced non-small cell lung cancer (NSCLC) that shows high levels of PD-L1 protein.
Patient Parameters
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Program Overview
The ARTEMIDE-Lung04 study aims to evaluate how well rilvegostomig works compared to pembrolizumab when used as the first treatment for patients with metastatic non-small cell lung cancer (mNSCLC) that has high PD-L1 expression. The study will also assess the safety of these treatments.
Description
This is a large, global study involving multiple centers, where participants will be randomly assigned to receive either rilvegostomig or pembrolizumab. The study is double-blind, meaning neither the participants nor the researchers will know which treatment is being given, to ensure unbiased results. The focus is on patients with advanced non-small cell lung cancer that cannot be cured with surgery and whose tumors express a protein called PD-L1. The study will monitor the effectiveness and safety of the treatments over time.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with non-small cell lung cancer (NSCLC), including all types.
- Cancer has spread to other parts of the body (Stage IV) and cannot be treated with surgery.
- No specific genetic mutations that have targeted treatments available.
- Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Expected to live at least 12 more weeks.
- Able to provide a tumor sample for testing.
- Have at least one tumor that can be measured accurately with scans.
- Have good organ and bone marrow function.
Exclusion Criteria
- Have severe or uncontrolled health conditions that could interfere with the study.
- Have had an organ transplant.
- Have autoimmune or inflammatory disorders needing long-term steroid or immunosuppressive treatment.
- Have had another cancer unless it was treated and inactive for at least 2 years.
- Have small cell or neuroendocrine cancer types.
- Have brain metastases unless they are stable and not needing treatment for at least 4 weeks.
- Have active immune system deficiencies or infections.
- Have active tuberculosis.
- Have received any previous treatment for advanced or metastatic NSCLC.
- Have been treated with anti-TIGIT or other immune-targeting therapies.
- Have been treated with anti-PD-1 or anti-PD-L1 therapies before.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33744 | Bay Pines | Florida |
| Research Site | 33756 | Clearwater | Florida |
| Research Site | 33705 | Saint Petersburg | Florida |
| Research Site | 62526 | Decatur | Illinois |
| Research Site | 50309 | Des Moines | Iowa |
| Research Site | 66209 | Leawood | Kansas |
| Research Site | 21702 | Frederick | Maryland |
| Research Site | 20910 | Silver Spring | Maryland |
| Research Site | 21204 | Towson | Maryland |
| Research Site | 11590 | Westbury | New York |
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