NCT05340309

Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer

A Phase II Study of Subcutaneous Atezolizumab in NSCLC Patients Using a Decentralized Clinical Trial Model

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests whether subcutaneous atezolizumab can be effectively given at home with medical care provided primarily using telemedicine in patients with non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study may help determine if a telemedicine based approach that gives atezolizumab at home using a version of the drug designed for subcutaneous injection under the skin is safe and feasible.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of home administration by a healthcare provider (HCP) of atezolizumab and recombinant human hyaluronidase (subcutaneous atezolizumab) at a dose of 1875 mg every 3 weeks (Q3W). II. To determine the feasibility of home administration, by mobile nursing, of subcutaneous atezolizumab at a dose of 1875 mg Q3W. SECONDARY OBJECTIVES: I. To determine patient satisfaction with home administration of atezolizumab. II. To determine healthcare provider and mobile nurse satisfaction with home administration of atezolizumab. III. To determine the feasibility of a cancer clinical trial conducted under a decentralized model with telehealth assessments. EXPLORATORY OBJECTIVES: I. To determine the patient enrollment and retention rate for a decentralized clinical trial. II. To determine the relationship between patient physical activity and toxicity. III. To compare patient, infusion nurse, and pharmacist time spent in care during in office and home administration cycles. IV. To compare efficacy of subcutaneous (SC) atezolizumab with known efficacy of intravenous (IV) atezolizumab. OUTLINE: Patients receive atezolizumab and recombinant human hyaluronidase SC over 3-8 minutes on day 1. Cycles repeat every 3 weeks for 1 year (early-stage lung cancer) or up to 2 years (late-stage lung cancer) in the absence of disease progression or unacceptable toxicity.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab and Recombinant Human Hyaluronidase	Given SC
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2022-12-07
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-04-22
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study