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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 : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE January 23, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03035890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer
Official Title  ICMJE Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer Metastatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Radiation Therapy + Immunotherapy
3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent
Interventions:
  • Radiation: Radiation
  • Drug: Immuno-Therapeutic Agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 6, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2017)
33
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035890
Other Study ID Numbers  ICMJE WVU010516
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE West Virginia Clinical and Translational Science Institute
Investigators  ICMJE
Principal Investigator: Malcolm Mattes, MD WVUCI - Mary Babb Randolph Cancer Center
PRS Account West Virginia University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP