Study on Cemiplimab and Fianlimab Before Surgery for Treating Stage IB-IIIB Non-Small Cell Lung Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06918132

Provider View

This clinical trial is exploring whether a combination of two immunotherapy drugs, cemiplimab and fianlimab, given before surgery, can help treat patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The study aims to see if this approach can effectively reduce the cancer and improve outcomes for patients.

Patient Parameters

Program Overview

This phase II study is testing a combination of two immunotherapy drugs, cemiplimab and fianlimab, given before surgery to see if they can help treat patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The standard treatment for NSCLC often includes chemotherapy and immunotherapy before surgery to remove the cancer. Immunotherapy drugs like cemiplimab and fianlimab may help the immune system attack cancer cells and stop them from growing and spreading. By giving these drugs before surgery, the study hopes to kill more cancer cells and improve treatment outcomes for patients with stage IB-IIIB NSCLC.

Description

The main goal of this study is to see how well the combination of cemiplimab and fianlimab works in patients with early-stage NSCLC who have a specific protein marker (PD-L1) on their cancer cells. The study will measure how many patients have a major reduction in cancer cells after treatment.

Secondary goals include looking at how long patients live without the cancer coming back, overall survival rates, and any side effects from the treatment. Researchers will also explore various biological markers to understand how the treatment affects the cancer and the body.

Patients in the study will receive cemiplimab and fianlimab through an IV every 21 days for up to three cycles, as long as the cancer does not progress and there are no severe side effects. They will also have MRI scans, tissue and blood samples taken, and may undergo surgery to remove the cancer after treatment.

After finishing the study treatment, patients will have follow-up visits at 90 days, then every three months for the first two years after surgery, and every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of stage IB-IIIB non-small cell lung cancer (NSCLC) based on specific medical criteria.
  • Tumors must be T4 based only on size (more than 7 cm) if applicable.
  • Lymph node status must be known.
  • Cancer cells must have PD-L1 expression of 1% or higher.
  • Complete surgical removal of the cancer must be possible.
  • Have measurable disease according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate lung function and blood counts as determined by specific tests.
  • Not be pregnant and agree to use effective contraception if of childbearing potential.
  • Agree to provide blood and tissue samples for research.
  • Willing to return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing individuals, or those not willing to use effective contraception.
  • Have specific genetic changes in the cancer that can be targeted by other treatments.
  • Have cancer that cannot be surgically removed or has spread to other parts of the body.
  • Have a history of certain lung diseases, autoimmune diseases, or require high doses of steroids.
  • Have had a heart attack in the past six months or have severe heart conditions.
  • Have uncontrolled infections or other serious health conditions.
  • Have active infections like HIV, hepatitis B, or hepatitis C unless well-controlled.
  • Be taking other investigational drugs or have had another cancer in the past three years, except for certain skin or localized cancers.
  • Have allergies to the study drugs or their components.
  • Have received a live vaccine within 30 days before starting the study.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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