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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)

Primary Purpose

Early Stage Non-Small Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Avelumab

SBRT

About this trial

This is an interventional treatment trial for Early Stage Non-Small Cell Lung Cancer focused on measuring cancer, Non-Small Cell Lung Cancer, SBRT, Avelumab, Stereotactic Body Radiation Therapy, radiation, NSCLC, PD-1, PD-L1, Immunotherapy, Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

UC San Diego Moores Cancer Center
Sanford Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT+Avelumab

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).

Measured Via Adverse Events

Relapse free survival (RFS)

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.

Secondary Outcome Measures

Loco-regional control (LRC)

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

Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab

Full Information

NCT ID

NCT03050554

First Posted

February 2, 2017

Last Updated

April 29, 2021

Sponsor

Andrew Sharabi

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03050554

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

Funding

Study Start Date

October 26, 2017 (Actual)

Primary Completion Date

October 7, 2019 (Actual)

Study Completion Date

October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew Sharabi

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Stage Non-Small Cell Lung Cancer

Keywords

cancer, Non-Small Cell Lung Cancer, SBRT, Avelumab, Stereotactic Body Radiation Therapy, radiation, NSCLC, PD-1, PD-L1, Immunotherapy, Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SBRT+Avelumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Avelumab

Intervention Description

Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)

Primary Outcome Measure Information:

Title

Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).

Description

Measured Via Adverse Events

Time Frame

6 months

Title

Relapse free survival (RFS)

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Loco-regional control (LRC)

Description

Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented

Time Frame

3 years

Title

Overall survival in patients after completion of SBRT in combination with Avelumab

Description

Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Sharabi, M.D., Ph.D.

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC San Diego Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Sanford Health

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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