Study on Pembrolizumab Before and After Surgery for Early Stage Non-Small Cell Lung Cancer

Sponsor: Neal Ready MD PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02818920

Provider View

This clinical trial is exploring the use of pembrolizumab, an immunotherapy drug, given before and after surgery to see if it can help the immune system fight early stage non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

This study is testing pembrolizumab, an immunotherapy drug, to see if it can help the immune system fight early stage non-small cell lung cancer (NSCLC). Participants will receive two doses of pembrolizumab before surgery and four doses after surgery. The study aims to understand how pembrolizumab affects immune cells, particularly those that can recognize and attack cancer cells. Pembrolizumab is already approved for advanced lung cancer, but its use in this setting is still being researched.

Description

Pembrolizumab works by blocking a specific receptor (PD-1) on immune cells, which can help activate them to attack cancer cells. This study is investigating whether pembrolizumab can increase the number of immune cells that target cancer cells in early stage lung cancer. The treatment involves giving pembrolizumab before and after surgery to see if it can improve outcomes for patients. Researchers will study the changes in immune cells and the tumor environment to better understand how pembrolizumab works. The study also aims to see if this approach can provide clinical benefits, as larger trials are ongoing to determine if pembrolizumab can improve survival after surgery for early stage lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Cancer stage IB (3 cm or larger), IIA/IIB, or IIIA that can be surgically removed.
  • Primary tumor must be 3 cm or larger to ensure enough tissue is available after surgery.
  • Must be a candidate for surgery.
  • Good overall health with a performance status of 0 or 1.
  • No previous treatments like chemotherapy or radiation for current lung cancer.
  • Adequate organ function.
  • Age 18 or older.
  • Not pregnant. Women of childbearing potential must test negative for pregnancy before starting the study.
  • No active invasive cancer in the past 2 years, except for non-melanoma skin cancer.
  • Must agree to provide blood samples for research.
  • Have measurable disease based on specific criteria.
  • Lung function tests must meet certain standards.

Exclusion Criteria

  • Recent treatment with unapproved drugs or investigational devices.
  • History of active tuberculosis (TB).
  • Allergic reaction to pembrolizumab or its ingredients.
  • Currently receiving other cancer treatments.
  • Previous treatment with similar immunotherapy drugs.
  • Active hepatitis B or C infection.
  • Unable to follow study procedures.
  • Active infection requiring treatment that could affect ability to tolerate therapy.
  • History of lung inflammation or pneumonitis.
  • Known HIV infection.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Diagnosis of immunodeficiency or receiving immunosuppressive therapy recently.
  • Another invasive cancer that is progressing or needs treatment.
  • Pregnant or breastfeeding, or planning to conceive during the study.
  • Recent major surgery or serious health conditions that could affect safety or ability to complete the study.
  • Recent non-oncology vaccine therapy.
  • Recent heart attack or uncontrolled heart conditions.
  • History of interstitial lung disease.
  • Psychiatric or substance abuse issues that could interfere with the study.
  • Prisoners or those involuntarily detained.

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