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

NCT03050554

Last updated date
Study Location
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Early Stage Non-Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Early Stage Non-Small Cell Lung CancerStereotactic Body Radiation Therapy (SBRT) Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
NCT03050554
  1. La Jolla, California
  2. Sioux Falls, South Dakota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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