Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer (STICk-IM-NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04650490
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This trial is a randomized, 2-arm, phase II study to determine the effect, if any, of the timing of stereotactic radiosurgery (SRS) relative to immune checkpoint inhibitor (IO) therapy in patients with non-small cell lung cancer (NSCLC) that has spread (metastasized) to the brain.

Condition or disease Intervention/treatment Phase
Brain Metastases Non Small Cell Lung Cancer Radiation: Stereotactic Radiosurgery Drug: Immunotherapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Trial of SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate SRS followed by IO
Participants will receive SRS followed by physician's choice of standard of care immunotherapy, given at the FDA-approved dose within 14 days of SRS.
Radiation: Stereotactic Radiosurgery
Timing of stereotactic radiosurgery relative to immunotherapy

Drug: Immunotherapy
Physician's choice of immunotherapy per standard of care

Experimental: Immediate IO followed by SRS
Participants will receive physician's choice of immunotherapy, given at the FDA-approved dose followed by SRS, if deemed appropriate, at the time of intracranial progression.
Radiation: Stereotactic Radiosurgery
Timing of stereotactic radiosurgery relative to immunotherapy

Drug: Immunotherapy
Physician's choice of immunotherapy per standard of care




Primary Outcome Measures :
  1. Intracranial progression free-survival [ Time Frame: from randomization through study completion, an average of 3 years ]
    Defined as defined as time to intracranial progression from randomization measured by by RANO-BM criteria for radiographic progression on contrast-enhanced brain MRI


Secondary Outcome Measures :
  1. Assess quality of life in each arm by the Functional Assessment of Cancer Therapy - Brain questionnaire [ Time Frame: 1 year ]
    as measured on a 5 point Likert-type scale from 0 (not at all) through 4 (very much) where the higher score reflects better quality of life

  2. Assess neurocognitive outcome in each arm by the Hopkins Verbal Learning Test - Revised [ Time Frame: 1 year ]
    as measured by recall scores with higher values indicating better outcomes

  3. Assess neurocognitive outcome in each arm by the Trail Making Test Parts A and B [ Time Frame: 1 year ]
    scored as average or deficient based on time to complete the activity

  4. Assess neurocognitive outcome in each arm by the Controlled Oral Word Association test [ Time Frame: 1 year ]
    scored as the number of words completed in one minute, with higher score indicating better outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients must have 1 to 15 newly diagnosed brain metastases, ≤3 cm in the largest dimension, with at least one metastasis measuring ≥0.5 cm.
  • Primary tumor histology must be one confirmed as one of the following:

    • Squamous NSCLC
    • Adenocarcinoma NSCLC
    • Not otherwise specified NSCLC
  • Patient must be able and willing to undergo a thin cut MRI at Duke, which is required for study entry.
  • Patient must be planned for immunotherapy treatment as their next systemic therapy, including monotherapy or in combination with chemotherapy.
  • Patients previously treated with a tyrosine kinase inhibitor (TKI) may be eligible, if a second line (or later) immunotherapy regimen is planned.
  • Patients must be asymptomatic or minimally symptomatic, requiring the equivalent of ≤2 mg dexamethasone/day for at least 7 days prior to enrollment.
  • Female and male subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in the Duke Contraception Policy.
  • Age ≥18 years of age at the time of entry into the study.
  • Karnofsky Performance Score (KPS) ≥70.
  • Prothrombin and Partial Thromboplastin Times ≤1.2 x normal
  • Neutrophil count ≥1000
  • Hemoglobin ≥9 g/dl
  • Platelet count ≥100,000/µl
  • Creatinine ≤1.2 x normal range.

Exclusion Criteria:

  • Patients on the equivalent of >2 mg of dexamethasone daily ≤ 7 days before receiving study treatment
  • Patients who have previously receive whole brain radiation therapy (WBRT).
  • Patients must not have ever received immunotherapy in the stage IV setting. Prior immune therapy as part of treatment for stage I-III disease is allowed assuming an interval >6 months has passed from the completion of that therapy.
  • Patients with leptomeningeal disease. However, patients with discrete dural-based lesions may be eligible.
  • Females who are pregnant or breast-feeding.
  • Patients with an impending, life-threatening cerebral hemorrhage or herniation, based on the assessment from a brain MRI of the study neurosurgeons or their designate.
  • Patients with severe, active co-morbidity, defined as follows:

    • Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
    • Patients with known immunosuppressive disease or known uncontrolled human immunodeficiency virus infection
    • Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)
  • Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used:
  • Patients with prior, unrelated malignancy requiring current active treatment in the last 3 years with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
  • Patients with a known history of hypersensitivity to the physician's choice of immune checkpoint inhibitor, or any components of the inhibitor.
  • Patients who have any contraindications to immunotherapy.
  • Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months.
  • History and/or confirmed pneumonitis, or extensive bilateral lung disease on high resolution/spiral CT scan.

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): NCT04650490


Contacts
Layout table for location contacts
Contact: Scott Andrews, BSN RN 919 668 3726 william.s.andrews@duke.edu
Contact: Jennifer Mewshaw, MS NP 919 668 5211 jennifer.mewshaw@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke Cancer Center
Durham, North Carolina, United States, 27710
Contact: Scott Andrews, BSN RN    919-668-3726    william.s.andrews@duke.edu   
Contact: Jennifer Mewshaw, MS NP    919 668 5211    jennifer.Mewshaw@duke.edu   
Principal Investigator: Scott Floyd, MD PhD         
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Scott Floyd, MD PhD Duke University Health System
Principal Investigator: Jeffrey Clarke, MD Duke University Health System
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04650490    
Other Study ID Numbers: Pro00106340
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
immunotherapy
Stereotactic radiosurgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases