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

NCT03050554 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 161591
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Adverse Events

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

  6 months

• 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.

  3 years

Secondary Outcomes (2)

• Loco-regional Control (LRC)

  3 years

• Overall Survival in Patients After Completion of SBRT in Combination With Avelumab

  3 years

Study Arms (1)

SBRT+Avelumab

EXPERIMENTAL

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; Radiation: SBRT

Interventions

Avelumab DRUG

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

Also known as: Bavencio

SBRT+Avelumab

SBRT RADIATION

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

Also known as: Stereotactic Body Radiation Therapy

SBRT+Avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Sharabi: lead
• Pfizer: collaborator

Study Sites (2)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

avelumab; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Andrew Sharabi
• Organization: UC San Diego Moores Cancer Center

ansharabi@health.ucsd.edu

858-534-4808

Study Officials

• Andrew Sharabi, M.D., Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 13, 2017
• Study Start: October 26, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)