Metastatic Lung Small Cell CarcinomaPhase 2NCT04516070

Stereotactic Radiosurgery for the Treatment of Patients With Small Cell Lung Cancer Brain Metastasis

A Phase 2 study testing Questionnaire Administration and Stereotactic Radiosurgery in people with Metastatic Lung Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Brain, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8
What is being tested?: Questionnaire Administration and Stereotactic Radiosurgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 28 Aug 2020to 31 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 Eastern Cooperative Oncology Group (ECOG) =< 3
All patients must have histologic evidence suggesting small cell lung cancer. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
Patient has 10 or less brain metastases on contrast-enhanced brain MRI scan obtained no greater than 6 weeks prior to study registration. Biopsy of brain metastasis is not required. A patient may be enrolled with zero brain metastasis assuming that the SRS is to be directed at the post-operative surgical cavity of a resected metastasis.
Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist
Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
Patients should have normal coagulation [International Normalized Ratio (INR) < 1.3]. within 28 days of enrollment.

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Patient's primary language is English
No prior radiation therapy to the brain, including WBRT, PCI, or SRS
Performance Status Assessment
Standard ECOG performance status assessment will be used and determined by the treating physician

Who cannot join

Patients are excluded if they have a history of metastatic cancer in addition to small cell malignancy or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
Patients are excluded if there is radiographic evidence of leptomeningeal disease
Patients are excluded if there are malignant cells identified in the CSF on cytologic examination
Patients are not excluded for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the CSF
Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding
Patients are excluded if they are unable to obtain an MRI scan for any other reason, including gadolinium allergy
Patients are excluded with medical history of a psychiatric or neurologic illness, or other comorbidities believed to affect cognitive function. Subjects with neurocognitive deficit related to brain metastasis are an exception to this criterion and may qualify for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Stereotactic Radiosurgery (SRS) as Definitive Management for a Limited Number of Small Cell Lung Cancer (SCLC) Brain Metastasis

This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients' brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.

Read the detailed description

PRIMARY OBJECTIVE:

To estimate the cognitive decline rate at 3 months.

SECONDARY OBJECTIVES:

To examine cognitive decline rate on each individual cognitive test at each time point.

II. To examine cognitive decline rates using reliable change index methodology. III. To report the overall survival of patients (death due to any cause) of patients receiving stereotactic radiosurgery (SRS) for small cell lung cancer (SCLC) brain metastasis.

IV. To report rates of local tumor control (of the treated lesions) in the brain post-treatment, as dictated by magnetic resonance imaging (MRI) surveillance schedule above.

To report distant tumor control in the brain (of non-treated lesions) post-treatment, as dictated by MRI surveillance schedule above.

VI. To report time elapsed from SRS to whole brain radiation therapy (WBRT). VII. To report rate of intracranial toxicity of SRS in the setting of prior WBRT.

VIII. To report rates of intracranial toxicity of concurrent atezolizumab with SRS.

IX. To determine rates of systemic and intracranial disease control (time to progression) in those who are treated concurrently with atezolizumab and SRS.

To determine the rates of SCLC-specific survival. XI. To assess the pre-treatment factors and baseline characteristics in the predictive determination of local control, intracranial control, systemic control, and neurocognitive outcomes.

XII. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome.

XIII. To document post-treatment intracranial toxicity profile in patients after SRS.

CORRELATIVE OBJECTIVE:

Cerebral spinal fluid (CSF) biomarkers.

OUTLINE:

Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months after SRS.

Conditions: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Being tested: Questionnaire Administration, Stereotactic Radiosurgery
Medical subject headings: Small Cell Lung Carcinoma, Brain Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Questionnaire AdministrationOther
Ancillary studies
Stereotactic RadiosurgeryRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
Undergo SRS

Study groups in NCT04516070
Study group	Role	What they receive
Treatment (SRS)	Experimental	Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion. Receives: Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Cognitive decline
Will be defined as a decline of >= 1 standard deviation from baseline on at least 1 of the 5 cognitive tests. Will be estimated along with the 95% confidence interval. For patients with or without prior radiation therapy to the central nervous system, the cognitive decline rate will also be estimated respectively. Fisher exact test will be used to compare the neurocognitive decline rate at 3 month post-SRS in subgroups (e.g. prior therapy difference).
Measured: At 3 months post-stereotactic radiosurgery (SRS)
Incidence of adverse events
All toxicities will be assessed with National Cancer Institute predefined Common Terminology Criteria for Adverse Events version 5.
Measured: Up to 36 months

Secondary outcomes (13)

Cognitive decline
Will use descriptive statistics and boxplots to summarize and illustrate the neurocognitive function score at each assessment time.
Measured: Up to 36 months
Change in neurocognitive score
Will summarize and illustrate the change from baseline in neurocognitive score. Will also model the cognitive data with mixed effects regression including baseline neurocognitive scores, time, and number of lesions, extra-cranial disease, and a patient specific random effect.
Measured: Baseline, up to 36 months
Overall survival
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
Measured: Time from SRS until death or last follow-up, assessed up to 36 months
Small cell lung cancer (SCLC)-specific survival
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
Measured: Time from SRS till SCLC-related death or last follow-up, assessed up to 36 months
Time to neurocognitive decline
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
Measured: Time from date of SRS till the cognitive decline, assessed up to 36 months
Time duration from SRS to whole brain radiation therapy (WBRT)
Will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in subgroups (e.g. prior radiation treatment status). Cox proportional hazards regression will be used to model time to event survival as a function of age, performance status, extra-cranial disease, and other factors.
Measured: Time from SRS to the start of WBRT treatment, assessed up to 36 months
Local tumor control rates
Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate.
Measured: Up to 36 months
Distant tumor control rate
Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate.
Measured: Up to 36 months
Rate of systemic and intracranial disease control rate
Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate.
Measured: Up to 36 months
Response to SRS therapy
Will be determined by the radiology report. Will be estimated along with 95% confidence intervals. The association between the control rate and patient characteristics including pre-treatment factors (e.g. number of lesions) will be evaluated using Wilcoxon rank sum test or Fisher exact test. Logistic regression will be used to assess different patient clinical factor effect on the control rate.
Measured: Up to 36 months
Post-treatment intracranial toxicity profile
Will be summarized and documented.
Measured: Up to 36 months
Rate of intracranial toxicity of SRS in the setting of prior WBRT
Will be summarized according to intensity and treatment relationship, and categorized by System Organ Class.
Measured: Up to 36 months
Rate of intracranial toxicity concurrent atezolizumab with SRS
Will be summarized according to intensity and treatment relationship, and categorized by System Organ Class.
Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202031 Dec 2026

First posted17 Aug 2020
Study start28 Aug 2020
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Lung Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04516070
Sponsor's protocol ID: 2019-0900
Other IDs: NCI-2020-05720, 2019-0900
Status last verified: Sep 2026
First submitted: 13 Aug 2020
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Lung Small Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stereotactic Radiosurgery (SRS) as Definitive Management for a Limited Number of Small Cell Lung Cancer (SCLC) Brain Metastasis
ClinicalTrials.gov ID: NCT04516070
Acronym / sponsor ID: 2019-0900
Conditions: Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 55 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 28 Aug 2020 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 17 Aug 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.

Detailed description

PRIMARY OBJECTIVE:

To estimate the cognitive decline rate at 3 months.

SECONDARY OBJECTIVES:

To examine cognitive decline rate on each individual cognitive test at each time point.

IV. To report rates of local tumor control (of the treated lesions) in the brain post-treatment, as dictated by magnetic resonance imaging (MRI) surveillance schedule above.

To report distant tumor control in the brain (of non-treated lesions) post-treatment, as dictated by MRI surveillance schedule above.

VI. To report time elapsed from SRS to whole brain radiation therapy (WBRT). VII. To report rate of intracranial toxicity of SRS in the setting of prior WBRT.

VIII. To report rates of intracranial toxicity of concurrent atezolizumab with SRS.

IX. To determine rates of systemic and intracranial disease control (time to progression) in those who are treated concurrently with atezolizumab and SRS.

To determine the rates of SCLC-specific survival. XI. To assess the pre-treatment factors and baseline characteristics in the predictive determination of local control, intracranial control, systemic control, and neurocognitive outcomes.

XII. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome.

XIII. To document post-treatment intracranial toxicity profile in patients after SRS.

CORRELATIVE OBJECTIVE:

Cerebral spinal fluid (CSF) biomarkers.

OUTLINE:

Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months after SRS.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (SRS)	Experimental	Other: Questionnaire Administration, Radiation: Stereotactic RadiosurgeryPatients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients must have Eastern Cooperative Oncology Group (ECOG) =< 3
All patients must have histologic evidence suggesting small cell lung cancer. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
Patient has 10 or less brain metastases on contrast-enhanced brain MRI scan obtained no greater than 6 weeks prior to study registration. Biopsy of brain metastasis is not required. A patient may be enrolled with zero brain metastasis assuming that the SRS is to be directed at the post-operative surgical cavity of a resected metastasis.
Patients must be eligible to have all lesions treated with stereotactic radiosurgery as determined by the study radiation oncologist
Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital

Key exclusion criteria (7 listed)

Patients are excluded if they have a history of metastatic cancer in addition to small cell malignancy or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
Patients are excluded if there is radiographic evidence of leptomeningeal disease
Patients are excluded if there are malignant cells identified in the CSF on cytologic examination
Patients are not excluded for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the CSF
Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding

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
Questionnaire AdministrationAncillary studies	Other	Treatment (SRS)
Stereotactic RadiosurgeryAlso: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic RadiotherapyUndergo SRS	Radiation	Treatment (SRS)

Primary outcome

Cognitive decline
Time frame: At 3 months post-stereotactic radiosurgery (SRS)
Will be defined as a decline of >= 1 standard deviation from baseline on at least 1 of the 5 cognitive tests. Will be estimated along with the 95% confidence interval. For patients with or without prior radiation therapy to the central nervous system, the cognitive decline rate will also be estimated respectively. Fisher exact test will be used to compare the neurocognitive decline rate at 3 month post-SRS in subgroups (e.g. prior therapy difference).
Incidence of adverse events
Time frame: Up to 36 months
All toxicities will be assessed with National Cancer Institute predefined Common Terminology Criteria for Adverse Events version 5.

13 secondary outcomes

Cognitive decline
Time frame: Up to 36 months
Change in neurocognitive score
Time frame: Baseline, up to 36 months
Overall survival
Time frame: Time from SRS until death or last follow-up, assessed up to 36 months
Small cell lung cancer (SCLC)-specific survival
Time frame: Time from SRS till SCLC-related death or last follow-up, assessed up to 36 months
Time to neurocognitive decline
Time frame: Time from date of SRS till the cognitive decline, assessed up to 36 months
Time duration from SRS to whole brain radiation therapy (WBRT)
Time frame: Time from SRS to the start of WBRT treatment, assessed up to 36 months
Local tumor control rates
Time frame: Up to 36 months
Distant tumor control rate
Time frame: Up to 36 months
Rate of systemic and intracranial disease control rate
Time frame: Up to 36 months
Response to SRS therapy
Time frame: Up to 36 months
Post-treatment intracranial toxicity profile
Time frame: Up to 36 months
Rate of intracranial toxicity of SRS in the setting of prior WBRT
Time frame: Up to 36 months
Rate of intracranial toxicity concurrent atezolizumab with SRS
Time frame: Up to 36 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
MD Anderson Cancer CenterLink provided by the sponsor.

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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.

Jing Li principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cognitive decline (time frame: At 3 months post-stereotactic radiosurgery (SRS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04516070.

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 14 Sep 2026.