Stereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03050554 |
Recruitment Status :
Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : March 20, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Early Stage Non-Small Cell Lung Cancer | Drug: Avelumab Radiation: SBRT | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of the Safety, Tolerability, and Efficacy of Stereotactic Body Radiation Therapy (SBRT) Combined With Concurrent and Adjuvant Avelumab for Definitive Management of Early Stage Non-Small Cell Lung Cancer (NSCLC) |
Actual Study Start Date : | October 26, 2017 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: SBRT+Avelumab
SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles |
Drug: Avelumab
Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Radiation: SBRT SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) |
- Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events). [ Time Frame: 6 months ]Measured Via Adverse Events
- Relapse free survival (RFS) [ Time Frame: 3 years ]Relapse-Free Survival (RFS) is defined as the time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first. Death is considered as an event here.
- Loco-regional control (LRC) [ Time Frame: 3 years ]Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented
- Overall survival in patients after completion of SBRT in combination with Avelumab [ Time Frame: 3 years ]Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
- Known severe hypersensitivity reactions to monoclonal antibodies any history of anaphylaxis, or uncontrolled asthma
- Pregnancy or lactation
- Known alcohol or drug abuse
- Prior radiotherapy to the treatment site(s).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050554
United States, California | |
UC San Diego Moores Cancer Center | |
La Jolla, California, United States, 92093 | |
United States, South Dakota | |
Sanford Health | |
Sioux Falls, South Dakota, United States, 57104 |
Principal Investigator: | Andrew Sharabi, M.D., Ph.D. | University of California, San Diego |
Responsible Party: | Andrew Sharabi, Assistant Clinical Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03050554 |
Other Study ID Numbers: |
161591 |
First Posted: | February 13, 2017 Key Record Dates |
Last Update Posted: | March 20, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
cancer Non-Small Cell Lung Cancer SBRT Avelumab Stereotactic Body Radiation Therapy radiation |
NSCLC PD-1 PD-L1 Immunotherapy Lung |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |