Subcutaneous Atezolizumab for Treating Non-small Cell Lung Cancer

Sponsor: University of Southern California

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05340309

Provider View

This study is testing if atezolizumab, a cancer treatment, can be safely given at home using telemedicine for patients with non-small cell lung cancer. The treatment is given as an injection under the skin and may help the immune system fight cancer.

Patient Parameters

Program Overview

This phase II study is exploring whether atezolizumab, an immunotherapy drug, can be effectively administered at home for patients with non-small cell lung cancer (NSCLC) using telemedicine. Atezolizumab is a monoclonal antibody that may help the immune system attack cancer cells and prevent them from growing and spreading. The study aims to determine if this home-based approach is safe and practical.

Description

Primary Objectives:

  • To assess the safety of administering atezolizumab at home by a healthcare provider, using a subcutaneous injection every three weeks.
  • To evaluate the feasibility of home administration by mobile nursing services.

Secondary Objectives:

  • To measure patient satisfaction with receiving atezolizumab at home.
  • To assess healthcare provider and nurse satisfaction with home administration.
  • To explore the feasibility of conducting a cancer clinical trial using telehealth.

Exploratory Objectives:

  • To track patient enrollment and retention in a decentralized clinical trial.
  • To study the relationship between patient physical activity and treatment side effects.
  • To compare the time spent by patients, nurses, and pharmacists during home and office treatment cycles.
  • To compare the effectiveness of subcutaneous atezolizumab with its intravenous form.

Study Outline:

Participants will receive atezolizumab and recombinant human hyaluronidase as a subcutaneous injection over 3-8 minutes on the first day of each cycle. Treatment cycles repeat every three weeks for up to one year for early-stage lung cancer or up to two years for late-stage lung cancer, unless the disease progresses or side effects become unacceptable.

Eligibility Criteria

Inclusion Criteria

  • Have non-small cell lung cancer (NSCLC) eligible for atezolizumab treatment.
  • Be at least 18 years old.
  • Have detectable cancer on a CT or PET scan.
  • Have access to Wi-Fi or cellular data.
  • Be in good general health with a performance status of 0-2.
  • Have a life expectancy of at least 3 months.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must agree to use effective contraception during treatment and for 5 months after the last dose.

Exclusion Criteria

  • History of certain brain or spinal cord conditions.
  • Uncontrolled pain or fluid buildup in the body.
  • Active or history of autoimmune diseases, with some exceptions.
  • Significant heart or lung conditions.
  • Recent major surgery or severe infection.
  • Previous treatment with certain cancer therapies.
  • Current pregnancy or breastfeeding, or planning to become pregnant during or shortly after the study.
  • Known allergies to atezolizumab or its components.

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