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Lung Non-Small Cell CarcinomaPhase 2NCT05340309

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

A Phase 2 study testing Atezolizumab and Recombinant Human Hyaluronidase and Survey Administration in people with Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by University of Southern California at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab and Recombinant Human Hyaluronidase and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
7 Dec 2022to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Patients may be transfused to meet this criterion
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 2.5 x upper limit of normal (ULN) with the following exceptions (obtained within 14 days prior to initiation of study treatment):
  • Patients with documented liver metastases: AST and ALT =< 5 x ULN
  • Patients with documented liver or bone metastases: ALP =< 5 x ULN
  • Serum bilirubin =< 1.5 x ULN with the following exception (obtained within 14 days prior to initiation of study treatment)
  • Patients with known Gilbert disease: serum bilirubin =< 3 x ULN
  • Serum creatinine =< 1.5 x ULN or creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula) (obtained within 14 days prior to initiation of study treatment)
  • Serum albumin >= 25 g/L (2.5 g/dL) (obtained within 14 days prior to initiation of study treatment)
  • For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN (obtained within 14 days prior to initiation of study treatment)
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, as defined below:
  • Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception

Who cannot join

  • 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
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  • 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
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Active tuberculosis
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • History of malignancy other than lung cancer within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate > 90%), such as adequately treated carcinoma in situ of the cervix or bladder, non-melanoma skin carcinoma, localized prostate or resected differentiated thyroid cancer, ductal or lobular carcinoma in situ, or stage I uterine cancer
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Treatment with therapeutic IV antibiotics within 2 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment. However, Covid-19 vaccines administered under an FDA emergency use authorization are permitted
  • Current treatment with anti-viral therapy for hepatitis B virus (HBV)
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible
  • Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment
  • Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
  • Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Atezolizumab and Recombinant Human Hyaluronidase, Survey Administration
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab and Recombinant Human HyaluronidaseBiological

    Also called Atezolizumab + rHuPH20, Atezolizumab and Hyaluronidase, Atezolizumab with rHuPH20, Atezolizumab-rHuPH20

    Given SC

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT05340309
Study groupRoleWhat they receive
Treatment (atezolizumab and recombinant human hyaluronidase)ExperimentalPatients 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.
Receives: Biological: Atezolizumab and Recombinant Human Hyaluronidase; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: Up to 30 days after last dose

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Patient satisfaction with home administration of atezolizumab

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

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

  2. Healthcare provider and mobile nurse satisfaction with home administration of atezolizumab

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start7 Dec 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340309
Sponsor's protocol ID
2N-21-9
Other IDs
NCI-2022-02425, 2N-21-9, P30CA014089
Status last verified
Jan 2026
First submitted
11 Apr 2022
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yang L, Mutalib SI, Qi E, Zeng A, Thomas J, Hsu R, Kuhn P, Nocera L, Nieva J. At-home subcutaneous atezolizumab for non-small cell lung cancer: a prospective, single-arm phase II feasibility study. Lung Cancer Manag. 2026 Dec;15(1):2738583. doi: 10.1080/17581966.2026.2738583. Epub 2026 Oct 4.

    PubMed 42830627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Recombinant Human Hyaluronidase and Survey Administration in people with Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) of home administration by a healthcare provider (HCP) of subcutaneous atezolizumab (time frame: Up to 30 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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