A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC

  • STATUS
    Recruiting
  • End date
    Nov 16, 2022
  • participants needed
    30
  • sponsor
    Massachusetts General Hospital
Updated on 29 December 2021
cancer
tyrosine
lymphoma
systemic therapy
growth factor
pleural effusion
metastasis
liver metastasis
erlotinib
epidermal growth factor receptor
ROS1
EGFR
brain metastases
anaplastic lymphoma
targeted therapy
epidermal growth factor
crizotinib

Summary

This research study is studying a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (= oncogene-driven NSCLC) and for which the subject has been receiving treatment with a targeted biological agent such as erlotinib, crizotinib, or other drugs.

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. The investigational intervention in this study is SBRT with proton or photon radiation (explained below). "Investigational" means that the intervention is being studied. SBRT and proton radiation therapy are FDA approved radiation delivery systems. However, using it as a treatment for stage IV NSCLC is still investigational.

SBRT is a specialized, technologically advanced type of external beam radiation therapy that pinpoints high doses of radiation directly on the cancer. Because of high precision, these treatments spare healthy tissue and are associated with fewer side effects. SBRT is very different from conventional therapy where radiation is delivered in small doses given daily over the course of several weeks. For SBRT, the total dose of radiation is typically administered in 4-5 daily sessions. SBRT can be delivered with standard, so called photon radiation, or proton beam. Neither of these two types of radiation is generally superior over the other. There are technical differences between these two, and depending on tumor location, size, shape, and other factors, the investigators will decide which type of radiation to use for which treatment.

After the screening procedures confirm you are eligible to participate in the research study:

  • Each participant will receive stereotactic treatment course (SBRT with protons or photons) to the area of their tumor.

Details
Condition Non Small Cell Lung Cancer Metastatic, Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1), Targetable Oncogenes (EGFR, ALK, ROS1)
Treatment SBRT with protons or photons
Clinical Study IdentifierNCT02314364
SponsorMassachusetts General Hospital
Last Modified on29 December 2021

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