Study on NT-I7 and Atezolizumab for Untreated Advanced or Metastatic Lung Cancer with PD-L1 Expression

Sponsor: NeoImmuneTech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04984811

This clinical trial is testing a combination of NT-I7 and atezolizumab to see if it can effectively treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) that shows PD-L1 expression and has not been treated with systemic therapy before.

Patient Parameters

Program Overview

This study is looking at how well a combination of two drugs, NT-I7 and atezolizumab, works in treating patients with advanced or metastatic non-small cell lung cancer (NSCLC) that shows PD-L1 expression. The trial is open to patients who have not received any previous systemic treatment for their cancer. Up to 83 participants will be enrolled in this study, which will take place at multiple centers.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) and have not received any previous systemic treatment.
  • For locally advanced cases, the cancer must be Stage III and not suitable for surgery or definitive chemoradiation.
  • The cancer must show PD-L1 expression of 1% or higher.
  • Have measurable cancer that can be tracked during the study.
  • Agree to provide a biopsy sample to check PD-L1 levels.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function.

Exclusion Criteria

  • Have received any prior systemic anti-cancer therapy.
  • Have specific genetic mutations in the cancer (such as EGFR, ALK, BRAF, ROS, RED) that have available treatments.
  • Have had radiotherapy within two weeks before starting the study treatment.
  • Have active cancer spread to the brain or spinal cord, or have cancer in the membranes covering the brain and spinal cord.
  • Have had severe allergic reactions to monoclonal antibodies or intravenous immunoglobulin.
  • Have a history of autoimmune disease in the past two years.

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