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Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy

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ClinicalTrials.gov Identifier: NCT03176173
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.

Condition or disease Intervention/treatment Phase
Stage IV Non-Small Cell Lung Cancer Biological: Immunotherapy (standard of care) Radiation: Image Guided Radiation Therapy Other: Laboratory Biomarker Analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine if progression-free survival at 24 weeks with this treatment combination is improved compared to historical controls who received immunotherapy without radiation therapy.

SECONDARY OBJECTIVES:

I. Assess acute (0-6 months) and late (> 6 months) grade 3-5 toxicity. II. Assess overall survival. III. Correlate circulating tumor deoxyribonucleic acid (DNA) (ratio of post-radiation therapy [RT] to pre-RT level) with radiographic response.

IV. Correlate immune markers in peripheral blood with radiographic response.

TERTIARY OBJECTIVES:

I. Analyze progression-free survival with immune-related response criteria. II. Measure time to discontinuation of study immunotherapy agent. III. Assess patterns of progression.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while undergoing standard of care immunotherapy.

Arm II: Patients who decline to undergo radiation therapy receive standard of care immunotherapy.

After completion of study treatment, patients are followed up at 30 days and every 6 months thereafter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radical RADiotherapy and Immunotherapy for Metastatic CAncer of the Lung (RRADICAL)
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 28, 2020
Estimated Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm I (image guided radiation therapy)
Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while undergoing standard of care immunotherapy.
Biological: Immunotherapy (standard of care)
Receive standard of care immunotherapy (nivolumab, pembrolizumab, atezolizumab)
Other Name: biologic therapy

Radiation: Image Guided Radiation Therapy
Undergo image guided radiation therapy
Other Names:
  • IGRT
  • image-guided radiation therapy

Other: Laboratory Biomarker Analysis
Correlative studies

Active Comparator: Arm II (standard of care immunotherapy)
Patients who decline to undergo radiation therapy receive standard of care immunotherapy.
Biological: Immunotherapy (standard of care)
Receive standard of care immunotherapy (nivolumab, pembrolizumab, atezolizumab)
Other Name: biologic therapy

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: At 24 weeks after study entry ]
    Defined as proportion of patients without Response Evaluation Criteria in Solid Tumors version 1.1 disease progression or death 24 weeks from date of study entry.


Secondary Outcome Measures :
  1. Change in circulating tumor deoxyribonucleic acid levels as measured using CAncer Personalized Profiling by deep Sequencing [ Time Frame: Baseline up to 1 year after study entry ]
    Will correlate with radiographic response. Plasma biomarkers (e.g. cell free deoxyribonucleic acid level) will be summarized using medians and interquartile ranges; changes in biomarkers will be assessed using the Wilcoxon signed rank test. Correlation of biomarkers with radiographic response will be evaluated using a Wilcoxon rank sum test on patients with and without the event of interest. If feasible, these analyses will be supplemented by more formal analyses with the Cox model.

  2. Change in immune marker levels as measured from peripheral blood using flow cytometry performed by the Human Immune Monitoring Core at Stanford University [ Time Frame: Baseline up to 1 year after study entry ]
    Will correlate with radiographic response.

  3. Incidence of acute (0-6 months) and late (> 6 months) grade 3-5 toxicity [ Time Frame: Up to 4 years after study entry ]
    Measured with Common Terminology Criteria for Adverse Events version 4.

  4. Overall survival [ Time Frame: Time from study entry to death, assessed up to 4 years after study entry ]
    The electronic medical record will be monitored for patient deaths.


Other Outcome Measures:
  1. Patterns of response and progression [ Time Frame: Up to 4 years ]
    Patterns of response and progression, including abscopal responses will be measured.

  2. Progression free survival [ Time Frame: Up to 4 years ]
    Evaluated with immune-related Response Criteria.

  3. Time to discontinuation of study immunotherapy agent [ Time Frame: Up to 4 years ]
    Time to discontinuation of study immunotherapy agent will be measured.



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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:

  • Has metastatic non-small cell lung cancer (NSCLC)
  • Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks
  • Has had restaging imaging after initiation of immunotherapy, at least 4 weeks after pre-immunotherapy baseline imaging; computed tomography (CT) or positron emission tomography (PET)/CT of at least chest/upper abdomen must be performed within 4 weeks prior to registration; for patients with history of brain metastases, brain magnetic resonance imaging (MRI) or CT is required within 4 weeks of registration; for other patients brain MRI or CT is required within 12 weeks of registration
  • Is expected by the treating medical oncologist to continue on immunotherapy for at least three more months; imaging must show response, stable disease, or modest progression as determined by the treating medical oncologist; if there is modest progression, the patient must be clinically stable in terms of performance status and overall disease-related symptoms
  • Has at least one extracranial tumor safely treatable with radical-dose radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Untreated brain metastases, if not planned to be treated in this course of radiation therapy
  • Pregnancy or women of childbearing potential not willing/able to use contraception during protocol treatment

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): NCT03176173


Contacts
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Contact: Samantha Wong 650-498-8495 swong8@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Samantha Wong    650-498-8495    swong8@stanford.edu   
Principal Investigator: Michael Gensheimer         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Michael Gensheimer Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03176173     History of Changes
Other Study ID Numbers: LUN0088
NCI-2017-00952 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
40088 ( Other Identifier: Stanford IRB )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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