Berzosertib + Radiation for Brain Metastases from Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and assess the side effects of berzosertib, an experimental treatment, when combined with whole-brain radiation therapy for lung cancer that has metastasized to the brain. Berzosertib may inhibit tumor cell growth, while radiation uses x-rays to destroy cancer cells. The trial involves two groups: one receiving berzosertib with radiation and the other undergoing surgery in addition to these treatments. It seeks participants with lung cancer that has spread to the brain, who require symptom relief and can identify if they experience frequent seizures or need brain surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that berzosertib, when combined with treatments like cisplatin, is usually well-tolerated by patients with advanced solid tumors. This suggests it might also be safe to use with radiation therapy. However, as this combination is new, the study aims to determine the best dose and monitor for any side effects.
Whole-brain radiotherapy is a common and generally safe treatment for cancer that has spread to the brain. Although it can cause some changes in thinking and memory, it remains a standard method for treating brain tumors.
The trial tests these treatments together to ensure they are effective and safe. Currently in its early stages, the trial focuses on understanding the safety and correct dosage of this combination.12345Why are researchers excited about this trial's treatments?
Most treatments for brain metastases from lung cancer, like standard whole-brain radiotherapy, focus on broadly targeting cancerous areas. But berzosertib works differently, targeting a specific enzyme called ATR, which plays a critical role in repairing damaged DNA in cancer cells. By inhibiting ATR, berzosertib may make cancer cells more susceptible to radiation, potentially enhancing the effectiveness of the treatment. Researchers are excited because this combined approach could improve outcomes by making tumors less able to repair themselves, offering a new strategy that complements existing treatments.
What evidence suggests that this trial's treatments could be effective for brain metastases from lung cancer?
Research has shown that berzosertib, also known as M6620, can enhance the effectiveness of radiation therapy for treating lung cancer that has spread to the brain. Early studies demonstrated that berzosertib aids radiation in halting tumor growth by blocking certain proteins essential for cancer cell growth. In this trial, participants in Group I will receive whole-brain radiotherapy with berzosertib. Whole-brain radiotherapy is already known to shrink brain tumors. Participants in Group II will receive berzosertib before surgery, followed by whole-brain radiotherapy and additional berzosertib treatment. Together with berzosertib, these treatments might more effectively prevent cancer from worsening.23678
Who Is on the Research Team?
Pranshu Mohindra
Principal Investigator
Mayo Clinic Cancer Center LAO
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
Interventions
- Berzosertib (M6620 [VX-970])
- Whole-Brain Radiotherapy
Trial Overview
The trial is testing berzosertib combined with whole brain radiation therapy against standard care for patients with specific types of lung cancer that has spread to the brain. The goal is to find out if this combination works better than current treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive berzosertib IV over 60-90 minutes 2-4 hours prior to surgery. After surgery, patients undergo whole-brain radiation therapy and receive berzosertib as in Group I.
Patients undergo whole-brain radiation therapy QD 5 days a week for 15 fractions. Patients also receive berzosertib IV over 60-90 minutes twice a week, 18-30 hours after first radiation therapy. Treatment continues for 3 weeks in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Published Research Related to This Trial
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT02589522?term=VE-822%20OR%20VX-970%20OR%20M6620%20OR%20berzosertib&viewType=Table&rank=2Study Details | Testing the Safety of M6620 (VX-970) When ...
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
ATR inhibitor M6620 (VX-970) enhances the effect of radiation ...
M6620 enhances the effect of radiation in our preclinical NSCLC brain metastasis models, supporting the ongoing clinical trial (NCT02589522) evaluating M6620 in ...
3.
aacrjournals.org
aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-21-0305/673580/p/ATR-Inhibitor-M6620-VX-970-Enhances-the-Effect-ofATR Inhibitor M6620 (VX-970) Enhances the Effect of ...
M6620 enhances the effect of radiation in our preclinical NSCLC brain metastasis models, supporting the ongoing clinical trial (NCT02589522) evaluating M6620 ...
Berzosertib + Radiation for Brain Metastases from Lung ...
Giving berzosertib together with radiation therapy may work better compared to standard of care treatment, including brain surgery and radiation therapy, in ...
Phase I Study of ATR Inhibitor M6620 in Combination With ...
This report is the first of an ATR inhibitor-chemotherapy combination. The maximum dose of topotecan plus M6620 is tolerable.
Testing the Safety of M6620 (VX-970) When Given With ...
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
Clinical Trials
The purpose of this study is to assess the side effects and best dose of ATR kinase inhibitor VX-970 when given together with whole brain radiation therapy for ...
Phase 1 study of the ATR inhibitor berzosertib in ...
Berzosertib plus cisplatin is well tolerated and shows preliminary clinical activity in patients with advanced solid tumours, warranting further evaluation in ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.