Study on Using Radiation to Enhance Immunotherapy in Advanced Lung and Head/Neck Cancer

Sponsor: John L. Villano, MD, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03313804

Provider View

This clinical trial is exploring whether adding a short course of radiation to the standard immunotherapy treatment can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC).

Patient Parameters

Program Overview

The study aims to see if giving a short course of radiation to a single tumor site can help the immune system better fight cancer when combined with immune checkpoint inhibitors like Nivolumab, Atezolizumab, or Pembrolizumab. This approach is being tested in patients with advanced non-small cell lung cancer (NSCLC) and head/neck squamous cell cancer (HNSCC) who are starting these immunotherapy treatments. The main goal is to see if this combination can help patients live longer without their cancer getting worse over six months, compared to past results.

Description

Patients with advanced or returning non-small cell lung cancer (NSCLC) or head/neck squamous cell cancer (HNSCC) who are starting standard immunotherapy will be included in this study. They will receive a short course of radiation to a single tumor site within 14 days of starting immunotherapy. The radiation can be given in two ways: either as Stereotactic Body Radiation Therapy (SBRT) with a high dose or as a fractionated radiation therapy with a lower dose spread over several sessions. The choice of radiation method will be made by the treating doctor and will target a single tumor that is at least 1 cm in size. The goal is to see if this combination can improve the body's immune response to the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic non-small cell lung cancer or head/neck squamous cell cancer with a tumor at least 1 cm in size.
  • Eligible for radiation therapy.
  • Have had previous treatments like chemotherapy, radiation, or surgery, with at least 21 days since the last treatment.
  • No major surgery within 14 days before starting the study treatment.
  • No other active cancers, except for certain skin cancers or cervical cancer that have been treated and disease-free for 3 years.
  • Be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Meet specific blood test requirements for neutrophils, platelets, liver and kidney function.
  • Women must not be pregnant or nursing and must use effective birth control during the study and for 3 months after.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have a serious active infection.
  • Have a serious non-healing wound or bone fracture.
  • Have previously been treated with immune checkpoint inhibitors.
  • Not eligible for immune checkpoint inhibitors due to certain health conditions like active hepatitis or uncontrolled immune disorders.
  • Have had major surgery or significant injury within 14 days before starting the study.
  • Have uncontrolled health issues like heart failure, recent heart problems, or high blood pressure.
  • Have active infections like HIV or chronic hepatitis B or C.
  • Have severe nerve damage.

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