Study on Using Atezolizumab After Surgery to Prevent Early Stage Non-small Cell Lung Cancer from Returning

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07388524

Provider View

This clinical trial is testing whether the drug atezolizumab, given after surgery, can help prevent early stage non-small cell lung cancer (NSCLC) from coming back. The study compares atezolizumab to the usual approach of monitoring patients without additional treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if atezolizumab, an immunotherapy drug, can help stop early stage non-small cell lung cancer (NSCLC) from returning after surgery. Typically, after surgery, patients are closely monitored without further treatment unless there are changes in their condition. Atezolizumab works by helping the immune system attack cancer cells and may prevent them from growing and spreading. The study will compare the effects of atezolizumab to standard observation to determine if it is a better approach for preventing cancer recurrence.

Description

The main goal of this study is to compare how long patients remain free of cancer after surgery when treated with atezolizumab versus just being observed. The study will also look at overall survival rates, cancer recurrence rates, and any side effects of the treatment.

Participants will be randomly assigned to one of two groups:

  • Group A (Observation): Patients will be monitored for one year without additional treatment. They will have regular CT scans and may provide blood samples.

  • Group B (Atezolizumab): Patients will receive atezolizumab through an IV or a combination of atezolizumab and an enzyme called hyaluronidase under the skin every three weeks for up to one year. They will also have regular CT scans and may provide blood samples.

After completing the study treatment, patients in Group B will have a follow-up visit after 30 days. All patients will then have follow-up visits every six months for three years, and then annually for seven more years, totaling ten years of follow-up.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IA3 or IB non-small cell lung cancer (NSCLC) and have had surgery to completely remove the cancer.
  • Tumor must not have small-cell characteristics.
  • Must have had adequate lymph node sampling during surgery.
  • Tumor must show a high level of a protein called PD-L1.
  • No specific genetic mutations (EGFR or ALK) that are known to affect treatment.
  • Must enroll in the study within 21 to 77 days after surgery.
  • Must have recovered from surgery.
  • No previous cancer treatments for the current lung cancer.
  • Must not have serious ongoing illnesses or infections.
  • No history of lung diseases that required steroids.
  • No active autoimmune diseases requiring treatment in the last two years.
  • No known allergies to atezolizumab.
  • No recent live vaccines.
  • No history of organ transplants.
  • Must not be on high-dose steroids or immunosuppressive medications.
  • Must be 18 years or older.
  • Must have good overall health and specific blood test results.
  • Women must not be pregnant or nursing and must use birth control.
  • Patients with controlled HIV or past hepatitis infections may participate.
  • No active infections requiring treatment.
  • Must have good heart function if there is a history of heart issues.

Locations

FACILITYZIPCITYSTATE
Alliance for Clinical Trials in Oncology60606ChicagoIllinois

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