Global Study Comparing Volrustomig Plus Chemotherapy to Pembrolizumab Plus Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05984277

Provider View

This clinical trial is testing two different treatment combinations for patients with metastatic non-small cell lung cancer (mNSCLC) to see which is more effective and safe. The study focuses on patients whose cancer does not have certain genetic changes and who have low levels of the PD-L1 protein.

Patient Parameters

Program Overview

The eVOLVE-Lung02 study aims to compare the effectiveness and safety of two treatment options for patients with metastatic non-small cell lung cancer (mNSCLC). One group will receive volrustomig combined with chemotherapy, while the other group will receive pembrolizumab combined with chemotherapy. The study will focus on patients whose cancer does not have specific genetic changes and who have low levels of the PD-L1 protein. Patients will be monitored through regular scans to check the progress of their cancer, and their overall survival will be tracked until the study ends. An independent committee of experts will review the safety and tolerability of the treatments.

Description

This study is for adults with metastatic non-small cell lung cancer (NSCLC) that has been confirmed through lab tests. The cancer should not have certain genetic changes, specifically in the EGFR, ALK, and ROS1 genes. Participants will be randomly assigned to one of two groups: one group will receive volrustomig with chemotherapy, and the other will receive pembrolizumab with chemotherapy. The effectiveness of the treatments will be assessed through regular tumor scans until the cancer progresses. All participants will be followed for survival throughout the study. An independent committee will ensure the safety and tolerability of the treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of squamous or non-squamous NSCLC.
  • Have stage IV NSCLC that cannot be treated with surgery or radiation to cure it.
  • The cancer must not have specific genetic changes in the EGFR, ALK, and ROS1 genes.
  • No other genetic changes that have approved targeted treatments available locally.

Exclusion Criteria

  • Have a mix of small-cell lung cancer and NSCLC or a rare subtype.
  • Have spinal cord compression.
  • Have brain metastases that are causing symptoms. If treated, must be symptom-free and off steroids for at least 14 days before starting the study. At least 2 weeks must have passed since whole brain radiotherapy.
  • Have had another primary cancer unless:
    1. It was treated with the intent to cure, with no active disease for at least 2 years and low risk of coming back.
    2. It was a non-melanoma skin cancer or lentigo maligna that was treated and shows no disease.
    3. It was carcinoma in situ that was treated and shows no disease.
  • Have any condition that could interfere with the study or affect the safety or results, as judged by the investigator.

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