Berzosertib + Radiation for Brain Metastases from Lung Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of berzosertib (M6620 \[VX-970\]) when given together with whole brain radiation therapy in treating patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread from the original (primary) tumor to the brain (brain metastases). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving berzosertib together with radiation therapy may work better compared to standard of care treatment, including brain surgery and radiation therapy, in treating patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop all current medications, but it does mention that ongoing phenytoin should be discontinued or switched to another medication with an 8-day washout period before starting the trial. Also, strong inhibitors or inducers of CYP3A4 should be avoided, and dexamethasone should be reduced to 8 mg or less per day if possible.
What data supports the effectiveness of the treatment Berzosertib + Radiation for Brain Metastases from Lung Cancer?
Research shows that combining whole-brain radiotherapy (WBRT) with other drugs like erlotinib and gefitinib can improve response rates in treating brain metastases from lung cancer. Additionally, berzosertib has shown preliminary effectiveness when combined with other treatments in advanced lung cancer, suggesting potential benefits when used with WBRT.12345
Is the combination of Berzosertib and whole-brain radiotherapy safe for treating brain metastases from lung cancer?
The safety of whole-brain radiotherapy (WBRT) has been evaluated in various studies, showing it can be associated with a decline in neurocognitive function (thinking and memory skills). Hippocampal avoidant WBRT (HA-WBRT) is a newer method designed to reduce this risk, but specific safety data for Berzosertib combined with WBRT is not available in the provided research.23467
How is the treatment with Berzosertib and radiation different for brain metastases from lung cancer?
The treatment with Berzosertib and radiation is unique because it combines a novel drug, Berzosertib, which targets DNA repair mechanisms in cancer cells, with whole-brain radiotherapy (WBRT), potentially enhancing the effectiveness of radiation by making cancer cells more sensitive to it. This approach differs from other treatments that typically combine WBRT with drugs like gefitinib or erlotinib, which target specific growth signals in cancer cells.24689
Research Team
Pranshu Mohindra
Principal Investigator
Mayo Clinic Cancer Center LAO
Eligibility Criteria
Adults with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread to the brain. They must be fit for whole brain radiation therapy and not pregnant or breastfeeding. Participants need functioning kidneys, a stable blood count, and agree to use contraception. Those who've had recent chemotherapy or certain treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive berzosertib intravenously and undergo whole-brain radiation therapy. Group I receives radiation 5 days a week for 15 fractions over 3 weeks, while Group II receives berzosertib prior to surgery followed by radiation as in Group I.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-ups every 2 months for 6 months, every 3-4 months for another 6 months, then every 6 months for 1 year.
Treatment Details
Interventions
- Berzosertib (M6620 [VX-970])
- Whole-Brain Radiotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor