Chemoradiation Followed by Durvalumab for Elderly or High-Risk Patients with Stage III Lung Cancer

Sponsor: Rush University Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04441138

Provider View

This study is testing a treatment plan for elderly or high-risk patients with stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The plan includes a combination of chemotherapy and radiation, followed by the drug Durvalumab.

Patient Parameters

Program Overview

The study aims to find out if Durvalumab can be safely given to elderly or high-risk patients with stage III non-small cell lung cancer (NSCLC) after they receive a specific type of chemotherapy and radiation treatment. The treatment plan involves four cycles of chemoradiation, followed by Durvalumab for up to a year, unless the cancer progresses or side effects become too severe.

Description

This clinical trial is designed for elderly patients (70 years or older) or those considered high-risk due to their health status, who have stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. The study involves a treatment plan that starts with a combination of chemotherapy and radiation therapy, given in four cycles over 12 weeks. After completing this initial treatment, patients will receive Durvalumab, a medication given through an IV, every four weeks for up to 12 months.

The main goals of the study are to see how many patients can complete the initial treatment and to assess the safety and side effects of Durvalumab in this group. Researchers will also look at how long patients live without the cancer getting worse and how many patients survive for at least a year after starting the treatment.

Participants will need to meet certain health criteria to join the study, including having a confirmed diagnosis of stage III NSCLC, being unable to have surgery, and having a life expectancy of more than six months. They must also have normal organ function and be able to provide informed consent. Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.

Eligibility Criteria

Inclusion Criteria

  • Must have stage III non-small cell lung cancer that cannot be removed by surgery.
  • Must be 70 years or older, or over 18 and considered high-risk due to health status.
  • Must have had a PET/CT scan and a brain scan to confirm no cancer spread to the brain.
  • Must have normal blood and organ function based on specific tests.
  • Must be able to provide informed consent and comply with study requirements.
  • Women must be post-menopausal or have a negative pregnancy test and use contraception.

Exclusion Criteria

  • History of severe allergic reactions to similar drugs used in the study.
  • Uncontrolled health issues like infections, heart problems, or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • HIV positive patients.
  • Participation in another clinical study within the last 6 months.
  • Recent cancer treatment that conflicts with the study schedule.
  • Active autoimmune or inflammatory disorders, unless stable and not requiring systemic treatment.
  • History of another cancer within the last 5 years, except for certain skin cancers or treated in situ cancers.
  • Active infections like tuberculosis, hepatitis B or C, or HIV.
  • Use of immunosuppressive medication within 14 days before starting the study.
  • Recent live vaccine within 30 days before starting the study.
  • Prior treatment with similar immunotherapy drugs that led to severe side effects.

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