SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer (STICk-IM-NSCLC)
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ClinicalTrials.gov Identifier: NCT04650490 |
Recruitment Status :
Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : November 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Brain Metastases Non Small Cell Lung Cancer | Radiation: Stereotactic Radiosurgery Drug: Immunotherapy | Phase 2 |
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 : | September 2023 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | September 2026 |

Arm | Intervention/treatment |
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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.
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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.
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Radiation: Stereotactic Radiosurgery
Timing of stereotactic radiosurgery relative to immunotherapy Drug: Immunotherapy Physician's choice of immunotherapy per standard of care |
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have 1 to 15 newly diagnosed brain metastases, ≤5 cm in the largest dimension, with at least one metastasis measuring ≥0.3 cm.
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Primary tumor histology must be one confirmed as one of the following:
- Squamous NSCLC
- Adenocarcinoma NSCLC
- Not otherwise specified NSCLC
- Patient must have an MRI of the brain within 4 weeks (28 days) of signing the study consent.
- 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.
Exclusion Criteria:
- Patients on the equivalent of >2 mg of dexamethasone (or prednisone/steroid equivalent) daily ≤ 7 days before receiving study treatment.
- Patients who have previously received 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 after an interval of >6 months has passed from the completion of that therapy.
- Patients with leptomeningeal carcinomatosis. However, patients with discrete dural-based lesions may be eligible at the discretion of the treating radiation oncologist.
- Females who are pregnant or breastfeeding.
- Patients with an impending, life-threatening cerebral hemorrhage or herniation, based on the assessment from a brain MRI of the study neurosurgeons or their designee.
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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, prostate cancer at stage I-III 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, including steroid of >10 mg prednisone daily or equivalent, within the past 3 months.

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
Contact: Heather Franklin, BSN RN | 919 668 3726 | heather.mccullough@duke.edu | |
Contact: Joan Cahill, BNS OCN CCRP | 919 668 5211 | Joan.Cahill@duke.edu |
United States, North Carolina | |
Duke Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Contact: Heather Franklin, BSN RN 919-668-3726 heather.mccullough@duke.edu | |
Contact: Joan Cahill, BSN OCN CCRP 919 668 5211 Joan.Cahill@duke.edu | |
Principal Investigator: Scott Floyd, MD PhD |
Principal Investigator: | Scott Floyd, MD PhD | Duke Health | |
Principal Investigator: | Jeffrey Clarke, MD | Duke Health |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04650490 |
Other Study ID Numbers: |
Pro00106340 |
First Posted: | December 2, 2020 Key Record Dates |
Last Update Posted: | November 14, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
immunotherapy Stereotactic radiosurgery |
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 |