Study on Vudalimab or Pembrolizumab with Chemotherapy as First Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Xencor, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06173505

Provider View

This clinical trial is testing two different drug combinations, vudalimab with chemotherapy and pembrolizumab with chemotherapy, to see which is more effective and safe as a first treatment for patients with advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to find the best dose of vudalimab to use with chemotherapy and to compare its effectiveness and safety against pembrolizumab with chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) who have not received any prior treatment for their metastatic disease.

Description

This is a Phase 1b/2 clinical trial involving multiple centers. It is open-label, meaning both the researchers and participants know which treatment is being administered. The study is for patients with advanced non-small cell lung cancer (NSCLC) that has not been treated before. In Part 1, researchers will determine the best dose of vudalimab, a drug that targets specific proteins involved in cancer growth, to use with standard chemotherapy. In Part 2, they will compare the effectiveness and safety of this combination against another treatment using pembrolizumab, a drug that also targets cancer growth proteins, with standard chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed.
  • Do not have specific genetic mutations or changes that can be treated with other approved therapies.
  • Have a PD-L1 test result showing a score of less than 49%.
  • Have not received any previous treatment for advanced or metastatic NSCLC.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have adequate liver, kidney, thyroid, and bone marrow function.

Exclusion Criteria

  • Have active cancer spread to the brain or spinal cord, unless treated and stable.
  • Have an active autoimmune disease.
  • Require treatment with steroids or other immune-suppressing drugs within 14 days before starting the study.
  • Have symptomatic lung disease.
  • Have HIV with low immune cell counts, high viral load, recent serious infections, or not on stable treatment.
  • Test positive for active hepatitis C or B infections.
  • Have any other serious or uncontrolled medical conditions that could affect safety or study participation.

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