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Comparing brain scans alone to brain scans with radiation for small cell lung cancer

MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Phase 3 Interventional SWOG Cancer Research Network · NCT04155034

This study tests whether using just MRI scans can help people with small cell lung cancer live as long as those who also get radiation to the brain, while possibly causing fewer side effects.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment668 (estimated)
Ages18 Years and up
SexAll
SponsorSWOG Cancer Research Network Research network
Drugs / interventionschemotherapy, Immunotherapy, radiation
Locations446 sites (Birmingham, Alabama and 445 other locations)
Trial IDNCT04155034 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of using magnetic resonance imaging (MRI) surveillance alone versus MRI surveillance combined with prophylactic cranial irradiation (PCI) in patients with small cell lung cancer. The study aims to determine if MRI alone can provide similar survival outcomes while potentially reducing side effects associated with radiation therapy. Patients will be randomized into two groups: one receiving PCI and MRI, and the other receiving only MRI scans over a specified period. The trial will also assess cognitive function and the incidence of brain metastases between the two approaches.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed small cell lung cancer who have no evidence of brain metastases.

Not a fit: Patients with a history of brain metastases or leptomeningeal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a less invasive treatment option that prolongs survival and minimizes side effects for patients with small cell lung cancer.

How similar studies have performed: Other studies have explored similar approaches, but this specific comparison of MRI alone versus MRI with PCI is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Where this trial is running

Birmingham, Alabama and 445 other locations

+396 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Extensive Stage Lung Small Cell CarcinomaLimited Stage Lung Small Cell CarcinomaLung Small Cell Carcinoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.