Study on the Safety and Effectiveness of Radiation Therapy Combined with Durvalumab for Treating Residual Lung Cancer

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04748419

Provider View

This clinical trial is testing whether adding a specific type of radiation therapy to the standard treatment with the drug Durvalumab can safely improve control of lung cancer that remains after initial treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining a special type of radiation therapy, called hypofractionated radiation therapy (hfRT), with the drug Durvalumab can safely and effectively control lung cancer that remains after initial treatment. The study will test different doses of radiation to find the safest and most effective level. Participants will receive this treatment after completing their initial chemotherapy and radiation therapy for stage III non-small cell lung cancer (NSCLC). Researchers will monitor participants every three months during the first two years of Durvalumab therapy, and then every 4-6 months after that, to see how well the treatment works and if it is safe.

Description

In this study, researchers are testing a new approach to treating stage III non-small cell lung cancer (NSCLC) that remains after initial treatment. The study involves using a type of radiation therapy called hypofractionated radiation therapy (hfRT) along with the drug Durvalumab. The radiation therapy will be given in two doses, starting at a lower level and increasing to find the safest and most effective dose. This treatment will begin one to two months after patients complete their initial chemotherapy and radiation therapy.

A total of 32 participants with stage III NSCLC will be enrolled in the study. They will be monitored closely to assess the safety of the treatment and how well it controls the cancer. Follow-up visits will occur every three months during the first two years of Durvalumab therapy, and then every 4-6 months after that, to track the progression of the disease and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage III non-small cell lung cancer (NSCLC), including specific types like squamous cell carcinoma or adenocarcinoma.
  • Eligible for or have completed initial chemotherapy and radiation therapy with at least two cycles of platinum-based chemotherapy.
  • Must understand their condition and agree to participate in the study by signing a consent form.
  • Aged 19 years or older.
  • In good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live for more than 12 weeks.
  • Have normal organ and bone marrow function as shown by specific blood tests.
  • Women must be post-menopausal or have a negative pregnancy test if they are of childbearing age.
  • Willing to follow the study protocol, including attending all treatment sessions and follow-up visits.

Exclusion Criteria

  • Involved in planning or conducting the study.
  • Previously treated with certain immune therapies like anti-PD-1 or anti-PD-L1.
  • Participating in another clinical trial with an investigational product in the last 4 weeks.
  • Have a mix of small cell and non-small cell lung cancer.
  • Have received sequential chemoradiation therapy for locally advanced NSCLC.
  • Cancer has progressed during initial treatment.
  • Have unresolved side effects from previous cancer treatments, except for certain conditions like hair loss.
  • Currently receiving other cancer treatments.
  • Had major surgery within 28 days before starting the study treatment.
  • History of organ transplantation.
  • Have certain autoimmune or inflammatory disorders, unless they are well-controlled.
  • Allergic to Durvalumab or its components.
  • Have uncontrolled illnesses or infections.
  • Have another primary cancer, unless it was treated with curative intent and is not active.
  • Have a history of immune deficiency or certain infections like tuberculosis or hepatitis.
  • Using immunosuppressive medication within 14 days before starting the study treatment.
  • Received a live vaccine within 30 days before starting the study treatment.
  • Pregnant or breastfeeding, or not willing to use birth control during the study.
  • Previously participated in a Durvalumab or Tremelimumab study.
  • Had severe immune-related side effects from previous treatments.
  • Previously received radiation therapy to certain areas of the body.
  • Judged by the investigator to be unsuitable for the study.
  • Have a prolonged QT interval on an ECG.

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