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

NCT05340309 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2N-21-9NCI-2022-02425P30CA014089
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs) of home administration by a healthcare provider (HCP) of subcutaneous atezolizumab

  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 .

  Up to 30 days after last dose

• Successful completion of home drug administration visits within the specified window

  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.

  Up to 2 years

Secondary Outcomes (2)

• Patient satisfaction with home administration of atezolizumab

  At end of cycle 3 and cycle 6 (each cycle is 21 days)

• Healthcare provider and mobile nurse satisfaction with home administration of atezolizumab

  At end of cycle 3 and cycle 6 (each cycle is 21 days)

Other Outcomes (2)

• Overall response rate

  Up to 2 years

• Progression free survival rate

  Up to 2 years

Study Arms (1)

Treatment (atezolizumab and recombinant human hyaluronidase)

EXPERIMENTAL

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.

Biological: Atezolizumab and Recombinant Human Hyaluronidase; Other: Survey Administration

Interventions

Atezolizumab and Recombinant Human Hyaluronidase BIOLOGICAL

Given SC

Also known as: Atezolizumab + rHuPH20, Atezolizumab and Hyaluronidase, Atezolizumab with rHuPH20, Atezolizumab-rHuPH20, Atezolizumab/rHuPH20 Co-formulation, Recombinant Human Hyaluronidase Mixed with Atezolizumab, Tecentriq/rHuPH20

Treatment (atezolizumab and recombinant human hyaluronidase)

Survey Administration OTHER

Ancillary studies

Treatment (atezolizumab and recombinant human hyaluronidase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-small cell lung cancer (NSCLC) patients who are eligible for treatment with atezolizumab for approved indications. These include the following:
• Locally advanced or metastatic 1st line patients whose tumors have high PD-L1 expression (PD-L1 stained \>= 50% of tumor cells \[TC \>= 50%\] or PD-L1 stained tumor-infiltrating immune cells \[IC\] covering \>= 10% of the tumor area \[IC \>= 10%\]), as determined by an Food and Drug Administration (FDA) - approved test, with no EGFR or ALK genomic tumor aberrations
• For the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving
• For adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on \>= 1% of tumor cells, as determined by an FDA-approved test
• Be willing and able to provide written informed consent/assent for the trial
• Be at least 18 years of age on day of signing informed consent
• Have detectable disease based on computed tomography (CT) and/or positron emission tomography (PET) scan
• Have ready access wifi or cellular data plan
• Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Ability to comply with the study protocol, in the investigator's judgment
• Life expectancy \>= 3 months
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (1500/uL) without granulocyte colony-stimulating factor support (obtained within 14 days prior to initiation of study treatment)
• Lymphocyte count \>= 0.5 x 10\^9/L (500/uL) (obtained within 14 days prior to initiation of study treatment)
• Platelet count \>= 100 x 10\^9/L (100,000/uL) without transfusion (obtained within 14 days prior to initiation of study treatment)
• Hemoglobin \>= 90 g/L (9 g/dL) (obtained within 14 days prior to initiation of study treatment)

You may not qualify if:

• History of leptomeningeal disease
• Untreated or treatment refractory brain metastases
• Uncontrolled tumor-related pain
• Patients requiring pain medication must be on a stable regimen at study entry
• Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
• Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Patients with indwelling catheters (e.g., PleurX) are allowed
• Patients with known HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \>= 200/uL, and have an undetectable viral load
• Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
• Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover \< 10% of body surface area

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

atezolizumab; Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Jorge J Nieva, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: December 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)