Study on Visugromab and Nivolumab, With or Without Docetaxel, for Second-Line Treatment in Metastatic Non-Squamous Lung Cancer

Sponsor: CatalYm GmbH

Sponsor score: 0

ClinicalTrials ID:NCT07246863

This clinical trial is exploring a new treatment combination for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who have not responded to their first treatment. The study is testing Visugromab and Nivolumab, with or without Docetaxel, to see if they can help control the cancer.

Patient Parameters

Program Overview

This study is testing a new combination of treatments for people with metastatic non-squamous non-small cell lung cancer (NSCLC) who did not respond to their first treatment. The trial is looking at how well Visugromab, an experimental drug, works with Nivolumab, a standard treatment, and whether adding Docetaxel, a chemotherapy drug, makes a difference. The study is divided into three parts, starting with a safety check, followed by a larger trial with different treatment groups, and ending with a final analysis to see how well the treatments work.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of stage IV non-squamous non-small cell lung cancer (NSCLC).
  • Do not have specific genetic mutations that require other targeted treatments.
  • Have previously tried one treatment for metastatic NSCLC that included a checkpoint inhibitor, but it did not work.
  • Have measurable cancer that can be tracked by doctors.
  • Have a life expectancy of at least 3 months.
  • Be in good overall health, able to carry out daily activities with minimal restrictions.

Exclusion Criteria

  • Have not received more than one previous treatment for advanced/metastatic NSCLC.
  • Do not have another cancer that needs treatment.
  • Do not have active cancer in the brain or spinal cord.
  • Do not have an active autoimmune disease that needed treatment in the last 3 months.
  • Do not have lung diseases like interstitial lung disease or pneumonitis that required treatment with steroids.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)35294-3300BirminghamAlabama
Duke University Medical Center27710DurhamNorth Carolina

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