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Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03035890
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

Brief Summary:
This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Metastatic Radiation: Radiation Drug: Immuno-Therapeutic Agent Not Applicable

Detailed Description:

Preclinical data suggest that radiation therapy may be uniquely suited to combine with immune checkpoint inhibitors, since radiation can disrupt a tumor's physical barriers to T-cell infiltration and augment antigen presentation, thus serving as an "in situ personalized vaccine" to activate the immune system and potentially enhance the systemic response.

The rationale for this study is to determine the safety and efficacy of combined immune checkpoint inhibitors and radiation therapy in metastatic non-small cell lung cancer patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Radiation Therapy + Immunotherapy
3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent
Radiation: Radiation
Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)
Other Name: Hypofractionated Radiation

Drug: Immuno-Therapeutic Agent

Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include:

  • Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle)
  • Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle)
  • Atezolizumab 1200 mg once every 3 weeks (21 day cycle)

These agents should be continued per standard of care until either disease progression or unacceptable toxicity.

Other Name: Immunotherapy




Primary Outcome Measures :
  1. Best Overall Response [ Time Frame: From the start of treatment until disease progression up to 2 years. ]
    Best overall response rate (complete and partial), measured on follow-up imaging as per immune-related Response Criteria (irRC) approx. every three months taking the smallest measurement recorded.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From the start of treatment until the date of documented progression or death assessed up to 2 years ]
    Disease status will be evaluated based on imaging results until progression or death; assessed every three months.

  2. Overall Survival [ Time Frame: From the start of treatment until the date date of death, or the last follow up date on which the participant was reported alive, assessed up to 2 years ]
    Amount of time from treatment until death, reported via follow up visit or phone call.

  3. Adverse event evaluation [ Time Frame: From the time of consent at 3 month intervals until 1 year after treatment has stopped or death ]
    Adverse event will be recorded and graded based on CTCAE version 4

  4. Quality of Life Assessment FACT-L [ Time Frame: 3 month intervals from the start of treatment until progression up to 2 years ]
    Access change in quality of life scores between visits using the FACT-L score. A difference of 3 points will be considered clinically significant.

  5. Quality of Life Assessment FACT-Fatigue [ Time Frame: 3 month intervals from the start of treatment until progression up to 2 years ]
    Access change in quality of life between visits using the FACT- Fatigue scores. A difference of 3 points will be considered clinically significant.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IV metastatic Non Small Cell Lung Cancer
  • Measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). There must be at least 1 visceral organ metastasis outside of the brain.
  • History of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy.
  • Participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. For those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less.
  • Life expectancy greater than 3 months

Exclusion Criteria:

  • Active autoimmune disease, primary immunodeficiency syndrome, HIV/AIDS, or hepatitis B or C
  • Oral corticosteroid dependency
  • Uncontrolled or untreated active brain metastases/CNS disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035890


Contacts
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Contact: Malcolm Mattes, MD 304-598-4000 mdmattes@hsc.wvu.edu
Contact: Carla Ross, RN 304-581-1158 cjross@hsc.wvu.edu

Locations
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United States, West Virginia
WVU Cancer Institute - Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Malcolm Mattes, MD    304-598-4706    mdmattes@hsc.wvu.edu   
Principal Investigator: Malcolm Mattes, MD         
Sub-Investigator: Mohammed Almubarak, MD         
Sub-Investigator: Geraldine Jacobson, MD         
Sub-Investigator: Patrick Ma, MD         
Sub-Investigator: Aaron Provenzano, DO         
Sub-Investigator: Gary Marano, MD         
Sub-Investigator: Timothy Eubank, PhD         
Sub-Investigator: Matthew Smolkin, MD         
Sponsors and Collaborators
West Virginia University
West Virginia Clinical and Translational Science Institute
Investigators
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Principal Investigator: Malcolm Mattes, MD WVUCI - Mary Babb Randolph Cancer Center
  Study Documents (Full-Text)

Documents provided by West Virginia University:
Informed Consent Form  [PDF] November 20, 2018


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Responsible Party: West Virginia University
ClinicalTrials.gov Identifier: NCT03035890     History of Changes
Other Study ID Numbers: WVU010516
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by West Virginia University:
NSCLC
Lung Cancer
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs