S1827 (MAVERICK) for Small Cell Lung Cancer

This study, called S1827 (MAVERICK), is looking at how to best prevent cancer from spreading to the brain in people with small cell lung cancer. It compares two approaches: using only regular brain MRI scans to watch for cancer spread, versus using MRI scans along with a type of radiation therapy called prophylactic cranial irradiation (PCI). PCI is radiation given to the brain to try and stop cancer from spreading there. The study wants to see if using only MRI scans, and delaying radiation until cancer actually appears, is just as good as or better for your lifespan, and if it causes fewer side effects. To join, you must have small cell lung cancer and no signs of cancer in your brain on a recent MRI. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 668 participants. Participants will be randomly assigned to one of two groups.
What's involved
You would either receive prophylactic cranial irradiation (PCI) for two weeks plus MRI scans at specific times over two years, or only receive MRI scans at specific times over two years.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to two years after you join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04155034

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
SWOG Cancer Research Network
~668 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Magnetic Resonance ImagingProphylactic Cranial Irradiation

At a glance

Recruiting sites
0 of 446 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From the date of registration to date of death due to any cause, assessed up to 2 years after randomization
Extensive Stage Lung Small Cell Carcinoma
Limited Stage Lung Small Cell Carcinoma
Lung Small Cell Carcinoma
446 sites across 54 states
Pennsylvania46
Wisconsin42
Ohio32
Illinois29
North Carolina26
Michigan24
Missouri18
Iowa14
  • Chad G Rusthoven · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)
Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease
Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with limited-stage (LS)-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including stereotactic body radiation therapy \[SBRT\] for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not required. Patients with extensive-stage (ES)-SCLC must have completed platinum-based chemotherapy either with or without thoracic radiotherapy at the discretion of the treating physician
All adverse events from prior treatment must have resolved to =\< grade 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) prior to randomization
Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (computed tomography \[CT\] or positron emission tomography \[PET\]/CT including the chest and abdomen) must be performed within 28 days prior to randomization
No more than 8 weeks may have elapsed between day 1 of the last cycle of chemotherapy and randomization
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis
Patient must have Zubrod performance status of 0-2
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment
Patient must not have any severe active comorbidities, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
Transmural myocardial infarction within 6 months prior to randomization
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter
Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 16 weeks prior to randomization
Note also that HIV testing is not required for eligibility for this protocol
Patient must not be pregnant because of fetal risks from radiation exposure. Men must have agreed to use an effective contraceptive method during PCI and for six months after completing PCI. Women of reproductive potential must have agreed to use an effective contraceptive method during PCI. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Patients who speak and understand English or French must agree to participate in cognitive function testing
Patient must be offered the opportunity to have specimens submitted for banking
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
As a part of the Oncology Patient Enrollment Network (OPEN) randomization process the treating institution?s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Overall survival (OS)From the date of registration to date of death due to any cause, assessed up to 2 years after randomization

    Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).