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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Andrew Sharabi, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE February 2, 2017
First Posted Date  ICMJE February 13, 2017
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE October 26, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • 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 ]
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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)
Brief 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.

Detailed Description This is a single arm open label Phase I/II study that will consist of two parts. In Phase I, investigators will assess the safety and tolerability of SBRT combined with Avelumab. In Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be candidates for enrollment. Subjects will receive definitive stereotactic body radiation (SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse events, serious adverse events, and laboratory abnormalities. Three blood draws will be obtained to analyze anti-tumor immune responses and immune correlates.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Stage Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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.)
Study Arms  ICMJE 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

Interventions:
  • Drug: Avelumab
  • Radiation: SBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
2
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2017)
56
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03050554
Other Study ID Numbers  ICMJE 161591
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew Sharabi, University of California, San Diego
Study Sponsor  ICMJE Andrew Sharabi
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Andrew Sharabi, M.D., Ph.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP