Study on Nivolumab and Chemotherapy, With or Without Radiation, Before Surgery for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

Sponsor: Montefiore Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05500092

Provider View

This clinical trial is testing whether adding a type of radiation therapy to a combination of nivolumab and chemotherapy before surgery can improve treatment outcomes for patients with certain stages of non-small cell lung cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if using nivolumab and chemotherapy, with or without a specific type of radiation therapy, before surgery can help control non-small cell lung cancer (NSCLC) that is in stages IIA to IIIB and can be surgically removed. The study will compare the effectiveness of the treatment with and without the additional radiation therapy.

Description

This study aims to compare two treatment approaches for patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). One group will receive nivolumab and chemotherapy, while the other group will receive the same treatment plus a specific type of radiation therapy directed at the lung tumor. The main goal is to see if the addition of radiation therapy can lead to a complete response, meaning no remaining cancer cells, after three cycles of treatment.

Secondary goals include evaluating the rate of major pathological response, which is defined as having 10% or less of viable cancer cells at the time of surgery, and assessing event-free survival, which means living without the cancer progressing or returning. The study will also explore other outcomes, such as disease-free survival, overall survival, and the safety of the treatments.

Researchers will also look at the presence of circulating tumor DNA (ctDNA) and perform genetic analyses on tumor and blood samples to identify potential predictors of treatment response. The study will monitor the safety and any side effects of the treatments, as well as the surgical outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IIA (tumors larger than 4 cm), IIB, IIIA, or IIIB non-small cell lung cancer (NSCLC) that can be surgically removed.
  • Have measurable disease based on standard criteria.
  • Lung tumor suitable for the specific type of radiation therapy used in the study.
  • Provide written informed consent and agree to the study's privacy terms.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have normal organ and bone marrow function, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Neutrophil count of at least 1500 per mm3.
    • Platelet count of at least 100,000 per mm3.
    • Normal liver and kidney function based on specific blood tests.
  • Women must be post-menopausal or have a negative pregnancy test if of childbearing potential.
  • Willing to comply with study procedures and follow-up visits.
  • No prior treatment for lung cancer.

Exclusion Criteria

  • Participating in another clinical study with an investigational product in the last 3 weeks.
  • Have another active primary cancer, except for certain treated cancers with no active disease.
  • Use of immunosuppressive medication within 14 days before starting nivolumab, with some exceptions.
  • Have significant nerve damage (Grade 2 or higher neuropathy).
  • Have received immunotherapy before.
  • Have active or recent autoimmune or inflammatory disorders requiring treatment, with some exceptions.
  • History of organ transplant.
  • Allergic to nivolumab or its components.
  • Have uncontrolled illnesses that would interfere with the study.
  • Have active infections, including tuberculosis or hepatitis B or C.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • History of lung diseases like interstitial lung disease or pneumonitis.
  • Received other cancer treatments within 30 days before starting the study.

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