Treating Early-stage Non-Small Cell Lung Cancer with Durvalumab and Radiation Therapy

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04716946

Provider View

This clinical trial is exploring whether combining the drug durvalumab with a specific type of radiation therapy, called stereotactic body radiation therapy (SBRT), is more effective for treating early-stage non-small cell lung cancer (NSCLC) than using SBRT alone.

Patient Parameters

Program Overview

The aim of this study is to determine if adding the drug durvalumab to stereotactic body radiation therapy (SBRT) can improve treatment outcomes for patients with early-stage non-small cell lung cancer (NSCLC). Researchers want to see if this combination is more effective than using SBRT by itself.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and agree to follow study requirements.
  • Age 18 or older.
  • Diagnosed with early-stage non-small cell lung cancer (Stage I to IIIA) without certain types of tumor spread.
  • Not eligible for or unwilling to have surgery due to medical reasons or personal choice.
  • Confirmed diagnosis of NSCLC through standard biopsy.
  • Good overall health with a performance status score of 0 or 1.
  • Suitable candidates for SBRT.
  • Predicted to have a less than 80% chance of being disease-free for 2 years based on a specific risk model.
  • Weigh more than 30 kg.
  • 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 75,000 per mm³.
    • Normal liver function tests, except for patients with Gilbert's syndrome.
  • Women must be post-menopausal or have a negative pregnancy test if pre-menopausal.
  • Life expectancy of at least 12 weeks.

Exclusion Criteria

  • Participating in another clinical study with an investigational product in the last 4 weeks.
  • Previous chest radiation that prevents SBRT for the current tumor.
  • Active or past autoimmune or inflammatory disorders, with some exceptions.
  • Unresolved side effects from previous cancer treatments, except for certain conditions.
  • Recent treatment with certain antibodies or chemotherapy.
  • Use of immunosuppressive medication within 14 days before starting durvalumab, with some exceptions.
  • Major surgery within 28 days before starting the study, except for certain local surgeries.
  • History of organ transplant.
  • Severe concurrent illnesses, including psychiatric disorders or other progressing cancers.
  • Active infections, including tuberculosis, hepatitis B or C, or HIV, unless controlled.
  • Lung disease or active heart disease.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Recent live vaccination.
  • Certain lung or esophagus conditions.
  • Known genetic mutations affecting treatment.
  • Known allergies to study drugs.
  • Previous participation in a durvalumab study.
  • Must not donate blood while on durvalumab therapy.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.