NCT03050554

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Andrew Sharabi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Stage Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2017-10-26
• Primary completion: 2019-10-07
• Completion: 2019-10-07
• First posted: 2017-02-13
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study