Global Study on Rilvegostomig or Pembrolizumab with Chemotherapy for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06692738

Provider View

This clinical trial is evaluating the effectiveness and safety of a new drug, rilvegostomig, combined with chemotherapy, for treating patients with metastatic squamous non-small cell lung cancer (NSCLC) that expresses PD-L1. The study compares this treatment to another drug, pembrolizumab, also combined with chemotherapy.

Patient Parameters

Program Overview

The ARTEMIDE-Lung02 study aims to determine if rilvegostomig, when used with chemotherapy, is effective and safe for patients with metastatic squamous non-small cell lung cancer (NSCLC) whose tumors show PD-L1 expression. This study is conducted globally and involves comparing rilvegostomig to pembrolizumab, both combined with chemotherapy, as a first treatment option for these patients.

Description

This Phase III study involves two groups of patients with metastatic squamous non-small cell lung cancer (NSCLC) that shows PD-L1 expression. The study is double-blind, meaning neither the patients nor the researchers know which treatment each patient is receiving. One group will receive rilvegostomig with chemotherapy, while the other group will receive pembrolizumab with chemotherapy. The goal is to see which combination works better as a first treatment for this type of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous non-small cell lung cancer (NSCLC) through lab tests.
  • Cancer is at Stage IV, meaning it has spread and cannot be cured with surgery.
  • No genetic mutations in the cancer that can be treated with other approved therapies.
  • Provide a tumor sample to confirm PD-L1 expression.
  • Have at least one tumor that has not been treated with radiation and can be measured accurately with scans.
  • Have good organ and bone marrow function.

Exclusion Criteria

  • Cancer has small cell or neuroendocrine components.
  • Brain metastases unless they are stable, not causing symptoms, and not requiring treatment for at least 4 weeks before starting the study.
  • Have received any previous treatment for advanced or metastatic NSCLC.
  • Have been treated with anti-PD-1 or anti-PD-L1 therapies before.
  • Have received any treatment targeting immune-regulatory receptors.
  • Have had another cancer unless it was treated successfully and has not been active for at least 2 years.
  • Have autoimmune or inflammatory disorders needing ongoing treatment with steroids or immunosuppressants.
  • Have an active immune deficiency or infectious disease.
  • Have an active tuberculosis infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.