Global Study on Rilvegostomig or Pembrolizumab with Chemotherapy for First-Line Treatment of Advanced Non-Squamous Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06627647
This clinical trial is comparing two treatments, rilvegostomig and pembrolizumab, both combined with chemotherapy, to see which is more effective and safe for patients with advanced non-squamous lung cancer that shows PD-L1 protein.
Patient Parameters
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Program Overview
The ARTEMIDE-Lung03 study aims to find out how well rilvegostomig works compared to pembrolizumab when each is combined with chemotherapy. This is for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that shows the PD-L1 protein. The study will look at how effective and safe these treatments are as the first option for patients.
Description
This is a large, international study where patients are randomly assigned to receive either rilvegostomig or pembrolizumab, both with chemotherapy, to treat advanced non-squamous non-small cell lung cancer (NSCLC) that shows the PD-L1 protein. The study is double-blind, meaning neither the patients nor the doctors know which treatment is being given, to ensure unbiased results. The goal is to see which treatment works better and is safer for patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced non-squamous non-small cell lung cancer (NSCLC).
- Cancer is at stage IV and cannot be treated with surgery.
- No specific genetic mutations that have targeted treatments available.
- Tumor shows PD-L1 protein.
- At least one tumor that can be measured and has not been treated with radiation.
- Good organ and bone marrow function.
Exclusion Criteria
- Cancer has small cell or neuroendocrine components.
- Brain cancer unless it is stable, not causing symptoms, and not needing treatment for at least 4 weeks.
- No previous treatment for advanced NSCLC, except if it was more than 12 months ago for early-stage disease.
- No previous treatment with certain immune therapies.
- No other active cancers unless treated and inactive for at least 2 years.
- No active autoimmune or inflammatory diseases needing ongoing treatment.
- No active immune system deficiencies or infections, including tuberculosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 92801 | Anaheim | California |
| Research Site | 90211 | Beverly Hills | California |
| Research Site | 92123 | San Diego | California |
| Research Site | 94121 | San Francisco | California |
| Research Site | 95403 | Santa Rosa | California |
| Research Site | 94598 | Walnut Creek | California |
| Research Site | 80124 | Lone Tree | Colorado |
| Research Site | 06902 | Stamford | Connecticut |
| Research Site | 06516 | West Haven | Connecticut |
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