Brain MetastasesPhase 2STICk-IM-NSCLCNCT04650490
SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer
A Phase 2 study testing Stereotactic Radiosurgery and Immunotherapy in people with Brain Metastases and Non Small Cell Lung Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Non Small Cell Lung Cancer
- What is being tested?
- Stereotactic Radiosurgery and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Brain Metastases, Non Small Cell Lung Cancer
- Being tested
- Stereotactic Radiosurgery, Immunotherapy
- Keywords
- immunotherapy, Stereotactic radiosurgery
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Timing of stereotactic radiosurgery relative to immunotherapy
ImmunotherapyDrug
Physician's choice of immunotherapy per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Immediate SRS followed by IO | Experimental | 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. Receives: Radiation: Stereotactic Radiosurgery; Drug: Immunotherapy |
| Immediate IO followed by SRS | Experimental | 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. Receives: Radiation: Stereotactic Radiosurgery; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression free-survival
Defined as defined as time to intracranial progression from randomization measured by by RANO-BM criteria for radiographic progression on contrast-enhanced brain MRI
Measured: from randomization through study completion, an average of 3 years
Secondary outcomes (4)
Assess quality of life in each arm by the Functional Assessment of Cancer Therapy - Brain questionnaire
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
Measured: 1 year
Assess neurocognitive outcome in each arm by the Hopkins Verbal Learning Test - Revised
as measured by recall scores with higher values indicating better outcomes
Measured: 1 year
Assess neurocognitive outcome in each arm by the Trail Making Test Parts A and B
scored as average or deficient based on time to complete the activity
Measured: 1 year
Assess neurocognitive outcome in each arm by the Controlled Oral Word Association test
scored as the number of words completed in one minute, with higher score indicating better outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study startMar 2023 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: failure to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Floyd, MD PhD, Principal investigator, Duke HealthJeffrey Clarke, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650490
- Sponsor's protocol ID
- Pro00106340
- Acronym
- STICk-IM-NSCLC
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04650490
- Acronym / sponsor ID
- STICk-IM-NSCLC / Pro00106340
- Conditions
- Brain Metastases, Non Small Cell Lung Cancer
- Keywords
- immunotherapy, Stereotactic radiosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failure to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SRS followed by IO | Experimental | Radiation: Stereotactic Radiosurgery, Drug: ImmunotherapyParticipants will receive SRS followed by physician's choice of standard of care immunotherapy, given at the FDA-approved dose within 14 days of SRS. |
| Immediate IO followed by SRS | Experimental | Radiation: Stereotactic Radiosurgery, Drug: ImmunotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Primary tumor histology must be one confirmed as one of the following:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiosurgeryTiming of stereotactic radiosurgery relative to immunotherapy | Radiation | Immediate IO followed by SRS, Immediate SRS followed by IO |
| ImmunotherapyPhysician's choice of immunotherapy per standard of care | Drug | Immediate IO followed by SRS, Immediate SRS followed by IO |
Primary outcome
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
4 secondary outcomes
Assess quality of life in each arm by the Functional Assessment of Cancer Therapy - Brain questionnaire
Time frame: 1 year
Assess neurocognitive outcome in each arm by the Hopkins Verbal Learning Test - Revised
Time frame: 1 year
Assess neurocognitive outcome in each arm by the Trail Making Test Parts A and B
Time frame: 1 year
Assess neurocognitive outcome in each arm by the Controlled Oral Word Association test
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Floyd, MD PhD principal investigator
Duke Health
Jeffrey Clarke, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiosurgery and Immunotherapy in people with Brain Metastases and Non Small Cell Lung Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial progression free-survival (time frame: from randomization through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.