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

Running, not enrolling · Phase 3

Conditions studied: Extensive Stage Lung Small Cell Carcinoma, Limited Stage Lung Small Cell Carcinoma, Lung Small Cell Carcinoma

In brief

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

Key facts

Study ID: NCT04155034
Run by: SWOG Cancer Research Network
People needed: 668
Starts: 2020-05-04
Expected to finish: 2029-11-15
Last updated by the study team: 2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 it is running

Katmai Oncology Group — Anchorage, Alaska, United States
Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
City of Hope Corona — Corona, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States
Tibor Rubin VA Medical Center — Long Beach, California, United States
Los Angeles General Medical Center — Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Veterans Affairs Medical Center - San Francisco — San Francisco, California, United States
City of Hope South Pasadena — South Pasadena, California, United States
Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
UCHealth University of Colorado Hospital — Aurora, Colorado, United States
UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
Memorial Hospital North — Colorado Springs, Colorado, United States
Poudre Valley Hospital — Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
Banner North Colorado Medical Center — Greeley, Colorado, United States
UCHealth Greeley Hospital — Greeley, Colorado, United States
UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
Saint Anthony Hospital — Lakewood, Colorado, United States
Medical Center of the Rockies — Loveland, Colorado, United States
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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