Study on Thoracic Radiotherapy and PD-1 and LAG-3 Inhibition for Locally Advanced Non-Small Cell Lung Cancer

Sponsor: Albert Einstein College of Medicine

Sponsor score: 0

ClinicalTrials ID:NCT06865339

Provider View

This clinical trial is exploring a new treatment approach for patients with locally advanced non-small cell lung cancer (LA-NSCLC) using a combination of immunotherapy drugs, cemiplimab and fianlimab, without chemotherapy, to see if it can effectively reduce tumors before radiation therapy.

Patient Parameters

Program Overview

The study aims to determine if using immunotherapy drugs cemiplimab and fianlimab before radiation therapy can effectively shrink tumors in patients with locally advanced non-small cell lung cancer (LA-NSCLC). This approach omits chemotherapy and focuses on the potential benefits of immunotherapy in enhancing the body's immune response against cancer cells.

Description

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, making up over 80% of cases. For patients with locally advanced NSCLC, the standard treatment usually involves a combination of chemotherapy and radiation therapy. However, this study is testing a new approach that uses immunotherapy drugs, cemiplimab and fianlimab, to boost the immune system's ability to fight cancer without the need for chemotherapy.

The study is based on previous research that showed promising results when using immunotherapy in patients with high levels of a protein called PD-L1. Patients with high PD-L1 levels may benefit more from immunotherapy alone, while those with lower levels might still need chemotherapy. The trial will explore if starting treatment with immunotherapy can help prepare the immune system to better attack cancer cells when followed by radiation therapy.

The treatment will be given in three phases: first, three cycles of immunotherapy, with chemotherapy added for patients with lower PD-L1 levels; second, radiation therapy, possibly with chemotherapy for those with lower PD-L1 levels; and third, additional cycles of immunotherapy to consolidate the treatment.

The study will also investigate the potential of combining two types of immunotherapy that target different immune checkpoints, PD-1 and LAG-3, to see if this combination can further enhance the treatment's effectiveness. The goal is to find a more personalized treatment approach for patients with locally advanced NSCLC, potentially leading to better outcomes and fewer side effects.

Eligibility Criteria

Inclusion Criteria

  • Have not received prior treatment for non-small cell lung cancer (NSCLC) and have a confirmed diagnosis with measurable disease.
  • Have stage II or III NSCLC that cannot be removed by surgery.
  • Have a tumor sample tested for PD-L1 expression.
  • Be eligible for standard non-surgical treatment for stage III NSCLC, including chemotherapy and radiation therapy followed by immunotherapy.
  • Have a PET/CT scan showing active cancer in the lungs or chest lymph nodes within 42 days before starting the study.
  • Have a brain MRI or head CT scan with contrast within 42 days before starting the study.
  • Have lung function tests within 42 days of starting the study.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have adequate organ function as determined by specific blood tests.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Provide written informed consent to participate in the trial.

Exclusion Criteria

  • Have a known mutation in the EGFR or ALK genes that affects treatment.
  • Have received prior treatment with PD-1, PD-L1, or LAG-3 inhibitors.
  • Are currently participating in another clinical trial or have used an investigational device recently.
  • Have another active cancer that requires treatment and affects life expectancy.
  • Have a history of lung inflammation requiring steroids or current lung inflammation.
  • Have a history of heart inflammation.
  • Have high levels of certain heart enzymes unless they return to normal within 24 hours.
  • Have active tuberculosis.
  • Have psychiatric or substance abuse disorders that interfere with the study.
  • Are pregnant or breastfeeding.
  • Have an autoimmune disease requiring treatment in the past two years.
  • Have a significant infection requiring antibiotics recently.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Have an immune deficiency or are on high-dose steroids or other immunosuppressive therapy.
  • Have an allergy to the study drugs or their components.
  • Have received a live vaccine recently.

Locations

FACILITYZIPCITYSTATE
Montefiore Einstein Comprehensive Cancer Center (MECCC)10461BronxNew York

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