Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

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.

Atezolizumab and Recombinant Human Hyaluronidase

Survey Administration

Sandy Tran

Jorge J. Nieva, MD

Jorge J Nieva, MD

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.

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.

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

Overall response rate (confirmed partial and complete responses) will be assessed. All responses must be confirmed on subsequent scan to be considered a true response. Tumor response will be assessed using RECIST 1.1.

Defined as from date of start of study to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first.

Determined by rates of grade 3 or greater non-hematologic AE assessment by clinical assessment. Grading will be based on the NCI CTCAE v5.0 .

The number of successfully completed home visits per patient and the number of patients who successfully completed all home administrations will be calculated and reported.

Patients will be surveyed at the end of cycle 3 and cycle 6 on satisfaction with the treatment process.

Pharmacists and treating nurses will be surveyed at the end of cycle 3 and cycle 6 on time spent in drug preparation and administration as well as satisfaction with treatment administration.

Spots Global Cancer Trial Database for atezolizumab and recombinant human hyaluronidase