Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06918132
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage IB Lung Cancer AJCC v8
  • Stage II Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Biospecimen Collection — PROCEDURE
    Undergo tissue and blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Fianlimab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Surgical Procedure — PROCEDURE
    Undergo SOC surgery

Study Details

This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.

Key Dates

Start date
Apr 29, 2025
Status verified
Feb 2026
Primary completion
Apr 29, 2027
Completion
Apr 29, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cemiplimab, fianlimab)
    Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle and fianlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening, tissue sample collection on study, and blood sample collection, CT, and PET/CT throughout the study. Patients may undergo SOC surgery post-treatment.

Primary Outcome Measure

Major pathologic response (MPR) rate (Group A) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Kaushal Parikh, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Rochester· Rochester, MN

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