TerminatedPhase 1/2

SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Stopped: Funding

United States2 participantsStarted 2017-10-26

Plain-language summary

The purpose of the study is to determine whether avelumab has an effect on cancer and body in combination with SBRT, a standard treatment for early stage non-small cell lung cancer (NSCLC). Avelumab is considered experimental because it is not approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer. Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting to deliver a high dose of radiation to the tumor over a short period of time. A positioning cushion such as Vac-lok will be used during radiation treatment that is custom made. This custom mold forms to the contours of the subjects body to allow for proper positioning comfort and stability.

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: * Tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3 * Stage I NSCLC and is deemed medically inoperable or refuses surgical resection. * Life expectancy ≥ 9 months. * Acceptable organ and marrow function Exclusion Criteria: * Prior organ transplantation, including allogeneic stem cell transplantation * Significant acute or chronic infections including: * Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Known history of HBV or HCV * Active autoimmune disease * Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible. * Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day * Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable * Current use of immunosuppressive medication, EXCEPT for the following: * intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection) * Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent * Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). * Cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior …

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

Adverse Events

Timeframe: 6 months

Relapse Free Survival (RFS)

Timeframe: 3 years

Trial details

NCT IDNCT03050554

SponsorAndrew Sharabi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-07

Results submitted2021-08-10

View on ClinicalTrials.gov More Early Stage Non-Small Cell Lung Cancer trials