Astra Zeneca ISABR Study: Testing Radiation and Immunotherapy for Early-Stage Lung Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03148327

Provider View

This study is exploring whether combining a new drug, durvalumab, with a type of precise radiation therapy can help treat early-stage lung cancer. Participants will either receive both treatments or just the radiation to see which works better.

Patient Parameters

Program Overview

This clinical trial is testing a new treatment approach for early-stage non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The study involves using a drug called durvalumab along with a precise form of radiation therapy called Stereotactic Ablative Body Radiotherapy (SABR). Researchers want to see if this combination is safe and if it can help control the cancer better than radiation alone. Participants will be randomly assigned to receive either the combination treatment or just the radiation. The study will also involve regular follow-up visits to monitor health and treatment effects.

Description

This study is designed to test the safety and effectiveness of combining a new drug, durvalumab, with a precise radiation therapy called SABR for treating early-stage non-small cell lung cancer (NSCLC) that cannot be surgically removed. The study will start with a small group of patients to ensure the combination is safe, focusing on potential side effects like lung, heart, and digestive issues. If safe, more patients will be randomly assigned to receive either the combination treatment or just the radiation.

Participants receiving the combination treatment will get durvalumab through an IV before starting radiation therapy. The radiation will be given in several sessions over a few weeks. Those in the radiation-only group will receive the same radiation schedule without durvalumab. The study will closely monitor for any serious side effects, and regular scans will be done to check the cancer's response to treatment.

Participants will have follow-up visits at UCLA to check their health and collect blood samples for research. The goal is to learn more about how the combination treatment works and if it can improve survival and quality of life for patients with this type of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a new diagnosis of non-small cell lung cancer that has not been treated.
  • Cannot have surgery due to medical reasons or personal choice.
  • Cancer must be in an early stage and not have spread to lymph nodes or other parts of the body.
  • Be 18 years or older.
  • Be in good general health with a performance status of 0 or 1.
  • Have normal blood and organ function based on specific medical tests.
  • Women must not be pregnant and must agree to use birth control if of childbearing potential.
  • Be willing to follow the study protocol, including attending all visits and treatments.

Exclusion Criteria

  • Poor general health with a performance status greater than 1.
  • Cancer that has spread to lymph nodes or other parts of the body.
  • Previous radiation therapy to the same lung area.
  • History of autoimmune diseases like lupus or rheumatoid arthritis.
  • History of lung diseases like pneumonitis.
  • Participation in another clinical study within the last 6 months.
  • Previous treatment with certain immune therapies.
  • History of another cancer unless treated and inactive for 5 years.
  • Heart issues like prolonged QT interval on ECG.
  • Use of immunosuppressive medication recently.
  • Severe side effects from previous cancer treatments.
  • History of organ transplant or immune deficiency.
  • Active infections like hepatitis or HIV.
  • Pregnant or breastfeeding women.
  • Any condition that might interfere with the study or its results.

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