Study on Durvalumab and Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04786093

This clinical trial is exploring the effects of combining a drug called Durvalumab with a type of targeted radiation therapy to see if it can improve the quality of life and treatment outcomes for patients with advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

This study is testing whether using Durvalumab, an immunotherapy drug, along with a precise form of radiation therapy called stereotactic radiotherapy, can help improve the quality of life and treatment results for people with advanced non-small cell lung cancer (NSCLC). Participants will receive either a standard schedule of radiation or a personalized schedule, and will be monitored for two years after treatment to see how they respond. The study will also track any side effects and how they are managed.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced non-small cell lung cancer confirmed by a biopsy and be eligible for immunotherapy.
  • Can have newly diagnosed or returning cancer.
  • Must have at least one cancer site causing symptoms or growing, with no more than 10 sites in total.
  • Cannot have had previous radiation or surgery to the area planned for treatment.
  • Brain metastases must be treated before starting the study.
  • If cancer is in major bones or spine, surgical stabilization may be needed.
  • Must be 18 years or older.
  • Open to all genders and ethnic groups.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have normal organ and bone marrow function based on specific blood tests.
  • Must agree to use effective birth control during the study and for 90 days after treatment.
  • Must have a life expectancy of more than six months.
  • Must weigh more than 30 kg.
  • Must be able to give informed consent and follow study requirements.

Exclusion Criteria

  • Have active or past autoimmune or inflammatory disorders, with some exceptions.
  • Have received two or more lines of systemic therapy for metastatic NSCLC.
  • Cannot be on other investigational cancer treatments.
  • Have untreated brain metastases.
  • Have cancer spread to areas too risky for radiation.
  • Have untreated spinal cord compression.
  • Have allergies to Durvalumab or similar drugs.
  • Have uncontrolled illnesses or infections.
  • Be pregnant or nursing.
  • Not willing to use birth control if of reproductive potential.
  • Participating in another clinical study with an investigational product recently.
  • Have unresolved side effects from previous cancer treatments.
  • Have had major surgery recently.
  • Have a history of organ transplantation.
  • Have another primary cancer, with some exceptions.
  • Have active infections like tuberculosis or hepatitis.
  • Have used immunosuppressive medication recently, with some exceptions.
  • Have received a live vaccine recently.
  • Be on certain medications that affect the immune system.

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