Study on the Safety and Effectiveness of Fianlimab, Cemiplimab, and Chemotherapy Compared to Cemiplimab and Chemotherapy in Treating Non-Small Cell Lung Cancer Before Surgery

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06161441

Provider View

This clinical trial is testing whether adding a new drug, fianlimab, to the standard treatment of cemiplimab and chemotherapy is safe and more effective for adults with non-small cell lung cancer (NSCLC) that can be surgically removed.

Patient Parameters

Program Overview

The study is exploring a new treatment combination for patients with non-small cell lung cancer (NSCLC) that can be treated with surgery. It involves using an experimental drug called fianlimab along with cemiplimab and chemotherapy. The goal is to see if this combination works better than the current standard treatment of cemiplimab and chemotherapy. Researchers are also looking at potential side effects, how the drugs are processed in the body, whether the body develops antibodies against the drugs, and how the treatment affects patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Adults with newly diagnosed non-small cell lung cancer (NSCLC) that can be completely removed by surgery, classified as stage II to IIIB (N2).
  • If imaging shows enlarged lymph nodes in the chest, a sample from these nodes is required.
  • No signs of cancer spread to other parts of the body, confirmed by a physical exam and imaging tests done within four weeks before starting the study.
  • Must have a test result for a specific protein called PD-L1.
  • Must be in good general health, able to carry out normal activities or only slightly restricted.
  • Must have healthy bone marrow, liver, and kidney function.

Exclusion Criteria

  • Cancer that cannot be surgically removed or has spread to other parts of the body.
  • Tumors with specific genetic changes in the EGFR or ALK genes.
  • Uncontrolled infections with HIV, hepatitis B, or hepatitis C.
  • Have received cancer treatments like immunotherapy, chemotherapy, or radiation in the past three years, except for certain hormone therapies for breast or other hormone-sensitive cancers.
  • History of heart inflammation (myocarditis).

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