- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050554
Stereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
California
-
La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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 |
Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles
SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
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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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
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
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3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Sharabi, M.D., Ph.D., University of California, San Diego
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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