Global Study on Rilvegostomig or Pembrolizumab for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Research Site33744Bay PinesFlorida
Research Site33756ClearwaterFlorida
Research Site33705Saint PetersburgFlorida
Research Site62526DecaturIllinois
Research Site50309Des MoinesIowa
Research Site66209LeawoodKansas
Research Site21702FrederickMaryland
Research Site20910Silver SpringMaryland
Research Site21204TowsonMaryland
Research Site11590WestburyNew York

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