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 16 February 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 on16 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with any actionable mutation or translocation in EGFR, ALK, or ROS1
Stage IV disease (AJCC Staging system 7th edition)
Within 6 months of initiating their first TKI treatment regimen
Stable or responding systemic disease to TKI (no evidence of progression) on the most recent staging studies. The complete extent of the current residual systemic disease must be deemed amenable to SBRT as per review of imaging studies by a radiation oncologist, based on the following criteria
Lung: 1-3 lesions (including the primary) of maximum size 5 cm in longest diameter. A minimum size 1 cm in the longest diameter is recommended. (Patients with a malignant pleural effusion prior to the start of TKI therapy will be considered eligible for SBRT if there is complete radiographic resolution of the effusion while on systemic therapy)
Spine: Bone lesions must be limited to the spine. A maximum of 2 spinal metastases will be considered for SBRT, with each site spanning 1-3 vertebral bodies. A minimum size of 1 cm in longest diameter is recommended. SBRT may target sclerotic lesions that persist following TKI therapy
GI: 1-4 liver metastases of maximum size 5 cm in longest diameter and/or 1-2 adrenal metastases of maximum 4 cm size in longest diameter. A minimum size of 1 cm in longest diameter is recommended
In addition
CNS: 1-4 brain metastases of maximum size 3cm in longest diameter. However, these should be treated with standard-of-care SRS and will not be defined as target lesions for purposes of this protocol
A maximum number of 5 target lesions outside the brain, excluding the lung primary, is recommended to ensure that enrollment is limited to patients with low-burden disease and that treatments can be delivered within the specified time frame
History of prior radiation therapy to brain or skeleton is allowed, but should have occurred > 2 months from enrollment
Age at least 18 years
Life expectancy of greater than 6 months
ECOG performance status 2
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative serum or urine pregnancy test within 2 weeks of registration for women of childbearing potential is required
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Residual hilar or mediastinal lymph node disease (size > 1cm in short-axis diameter on CT). Non-malignant etiologies for enlarged lymph nodes may be evaluated per standard clinical practice
Participants who have received prior radiation therapy to anatomical sites other than brain or skeleton
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients who are pacemaker or defibrillator-dependent as these devices may not be operated concurrently with delivery of proton beam radiation
Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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