Study on Radiation Therapy Followed by Atezolizumab for Stage II or III Non-small Cell Lung Cancer Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04310020

Provider View

This clinical trial is exploring the safety and effectiveness of using radiation therapy followed by the immunotherapy drug atezolizumab to treat patients with stage II or III non-small cell lung cancer (NSCLC). The study aims to understand the side effects and benefits of this treatment combination.

Patient Parameters

Program Overview

The purpose of this study is to test if radiation therapy, followed by the immunotherapy drug atezolizumab, is safe and effective for patients with stage II or III non-small cell lung cancer (NSCLC). Radiation therapy uses high-energy rays to kill cancer cells, and atezolizumab helps the immune system attack cancer cells. The study will look at how well this treatment works and what side effects it might have.

Description

In this study, patients with stage II or III non-small cell lung cancer (NSCLC) who are not candidates for surgery or combined chemotherapy and radiation will receive a specific type of radiation therapy called hypofractionated radiation therapy. This involves smaller doses of radiation given over a period of time to target the cancer cells more effectively and with fewer side effects.

After completing radiation therapy, patients will receive atezolizumab, an immunotherapy drug, through an IV infusion every 21 days for up to 12 months. Atezolizumab is designed to help the immune system recognize and attack cancer cells. Throughout the study, patients will have regular CT scans and may have MRI scans to monitor the cancer's response to treatment. Blood samples will also be collected for research purposes.

The study will follow patients for side effects and how well the treatment works, including how long patients live without the cancer getting worse and overall survival rates. After finishing the treatment, patients will have follow-up visits at 6 weeks, then every 12 months for the first year, and every 6 months until 3 years after starting the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Must have stage III NSCLC with a performance status of 2 or stage II NSCLC with a performance status of 0-2.
  • Must not be a candidate for surgery or combined chemotherapy and radiation.
  • Must have measurable or non-measurable disease as shown by CT or MRI scans.
  • Must have a brain scan with contrast within 28 days before starting the study.
  • Must have disease that fits within the radiation treatment guidelines.
  • May have had previous treatment for lung cancer, but at least 12 months must have passed since the last treatment.
  • Must have recovered from any side effects of previous major surgery.
  • Must meet specific blood count and organ function requirements.
  • Must not have a history of certain lung diseases or active autoimmune diseases.
  • Must not have an active infection or be pregnant or nursing.
  • Must agree to use effective contraception during and after the study.
  • Must not have active hepatitis B or C infections.
  • Must not have had another cancer, except for certain types, within the past three years.
  • Must agree to participate in optional specimen banking for future research.
  • Must provide informed consent to participate in the study.
  • Must be registered to the second step of the study within 42 days after completing radiation therapy.
  • Must not have received steroids or live vaccines within a specified time before the second step of the study.

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