Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer (NCT05340309) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Subcutaneous Atezolizumab for the Treatment of Non-small Cell Lung Cancer
United States5 participantsStarted 2022-12-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs) of home administration by a healthcare provider (HCP) of subcutaneous atezolizumab
Timeframe: Up to 30 days after last dose
2
Successful completion of home drug administration visits within the specified window