Study on Durvalumab vs Placebo with Radiation Therapy in Early Stage Non-Small Cell Lung Cancer (NSCLC) Patients and Osimertinib After Radiation in Patients with EGFR Mutation

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03833154

Provider View

This clinical trial is testing the effectiveness and safety of the drug Durvalumab combined with radiation therapy compared to a placebo in patients with early stage non-small cell lung cancer (NSCLC) that cannot be surgically removed. Another part of the study is evaluating the drug Osimertinib after radiation therapy in patients with a specific genetic mutation (EGFR).

Patient Parameters

Program Overview

This study is exploring two main treatments for patients with early stage non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The first part of the study compares the drug Durvalumab with a placebo, both given alongside standard radiation therapy, to see which is more effective in preventing cancer from worsening and improving survival. The second part focuses on patients with a specific genetic mutation (EGFR) and tests the effectiveness of the drug Osimertinib after radiation therapy.

Description

In this study, patients with early stage non-small cell lung cancer (NSCLC) that cannot be surgically removed will receive standard radiation therapy. They will be randomly assigned to receive either Durvalumab or a placebo. The main goal is to see if Durvalumab helps patients live longer without the cancer getting worse compared to the placebo.

Additionally, for patients whose cancer has a specific genetic mutation called EGFR, the study will test if taking Osimertinib after radiation therapy is effective in keeping the cancer from progressing over four years. The study will also look at the safety and overall survival of patients taking Osimertinib.

Participants will be monitored for side effects and the effectiveness of the treatments. The study aims to provide insights into better treatment options for patients with early stage NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Planned to receive standard radiation therapy as the main treatment.
  • Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Expected to live at least 12 more weeks.
  • Weigh more than 30 kg (about 66 pounds).
  • Provide a tumor tissue sample if available.
  • Have adequate organ and bone marrow function.
  • Patients with central or peripheral lung lesions are eligible.
  • Must have staging studies done during screening, including a PET-CT scan within 10 weeks.
  • Patients with a history of other lung cancers or multiple lung lesions are eligible with some exceptions.

Exclusion Criteria

  • Have a mix of small cell and non-small cell lung cancer.
  • Have had an organ transplant.
  • Have another primary cancer, with some exceptions.
  • Have an active immune system disorder.
  • Have a tumor with an EGFR mutation for the main cohort.
  • Have had previous immune therapy, with some exceptions.

For the Osimertinib cohort:

  • Must be 18 years or older.
  • Planned to receive standard radiation therapy as the main treatment.
  • Have a performance status score of 0, 1, or 2.
  • Patients with central or peripheral lung lesions are eligible.
  • Patients with a history of other lung cancers or multiple lung lesions are eligible with some exceptions.
  • Must have staging studies done during screening, including a PET-CT scan within 10 weeks.
  • Provide a tumor tissue sample if available.
  • Must have a confirmed EGFR mutation sensitive to EGFR-TKI.
  • Have adequate bone marrow and organ function.
  • Women must use effective birth control, and men must use condoms during the study.

For the Osimertinib cohort exclusion:

  • Have a mix of small cell and non-small cell lung cancer.
  • Taking medications that affect the liver enzyme CYP3A4.
  • Have heart conditions that affect the QT interval on an ECG.
  • Have had certain chemotherapy or EGFR TKI treatments before.
  • Have severe nausea, digestive issues, or previous bowel surgery affecting drug absorption.
  • Have a history of lung diseases like interstitial lung disease or radiation pneumonitis requiring steroids.

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