Study on How Fianlimab with Cemiplimab and Chemotherapy Works Compared to Cemiplimab and Chemotherapy for Treating Advanced Non-Small Cell Lung Cancer

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05800015

Provider View

This clinical trial is testing a new drug called fianlimab, combined with cemiplimab and chemotherapy, to see if it is more effective than cemiplimab and chemotherapy alone in treating advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study is exploring a new treatment for advanced non-small cell lung cancer (NSCLC) using a drug called fianlimab, along with cemiplimab and chemotherapy. The goal is to find out if this combination is better at treating the cancer compared to just using cemiplimab and chemotherapy. Researchers are also looking at what side effects might occur, how much of the drugs are in the blood at different times, if the body makes antibodies against the drugs, and how the treatment might improve quality of life.

Eligibility Criteria

Inclusion Criteria

  • Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation, or has spread to other parts of the body.
  • Have not received any previous treatment for recurrent or metastatic NSCLC.
  • Provide a tumor tissue sample for testing.
  • Have a specific test result for PD-L1 expression, as required for different phases of the study.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Have untreated or active brain or spinal cord cancer spread.
  • Have certain genetic mutations in the cancer that can be treated with other specific drugs.
  • Have had brain inflammation, meningitis, or uncontrolled seizures in the past year.
  • Have a history of certain lung diseases or lung inflammation that required strong medications.
  • Have known immune system deficiencies or significant autoimmune diseases that required treatment in the past two years.
  • Need ongoing treatment with high doses of steroids or have had significant immune suppression recently.
  • Have received certain previous cancer treatments, except for specific cases where treatment was completed a long time ago and side effects have resolved.

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