Clinical Trials /

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

NCT03176173

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy
  • Official Title: Radical RADiotherapy and Immunotherapy for Metastatic CAncer of the Lung (RRADICAL)

Clinical Trial IDs

  • ORG STUDY ID: IRB-40088
  • SECONDARY ID: NCI-2017-00952
  • SECONDARY ID: IRB-40088
  • SECONDARY ID: LUN0088
  • NCT ID: NCT03176173

Conditions

  • Stage IV Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Immunotherapy (standard of care)biologic therapyArm I (image guided radiation therapy)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (image guided radiation therapy)ExperimentalPatients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while undergoing standard of care immunotherapy.
  • Immunotherapy (standard of care)
Arm II (standard of care immunotherapy)Active ComparatorPatients who decline to undergo radiation therapy receive standard of care immunotherapy.
  • Immunotherapy (standard of care)

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:At 24 weeks after study entry
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:Will correlate with radiographic response.
Measure:Incidence of acute (0-6 months) and late (> 6 months) grade 3-5 toxicity
Time Frame:Up to 4 years after study entry
Safety Issue:
Description:Measured with Common Terminology Criteria for Adverse Events version 4.
Measure:Overall survival
Time Frame:Time from study entry to death, assessed up to 4 years after study entry
Safety Issue:
Description:The electronic medical record will be monitored for patient deaths.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Stanford University

Last Updated

August 26, 2020