Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT05340309 |
Recruitment Status :
Recruiting
First Posted : April 22, 2022
Last Update Posted : February 13, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 11, 2022 | ||||
First Posted Date ICMJE | April 22, 2022 | ||||
Last Update Posted Date | February 13, 2024 | ||||
Actual Study Start Date ICMJE | December 7, 2022 | ||||
Estimated Primary Completion Date | December 7, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer | ||||
Official Title ICMJE | A Phase II Study of Subcutaneous Atezolizumab in NSCLC Patients Using a Decentralized Clinical Trial Model | ||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (atezolizumab and recombinant human hyaluronidase)
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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
37 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 7, 2026 | ||||
Estimated Primary Completion Date | December 7, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05340309 | ||||
Other Study ID Numbers ICMJE | 2N-21-9 NCI-2022-02425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2N-21-9 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | University of Southern California | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Southern California | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Southern California | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |