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ATR Kinase Inhibitor
Berzosertib + Radiation for Brain Metastases from Lung Cancer
Phase 1
Waitlist Available
Led By Pranshu Mohindra
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of M6620 (VX-970, berzosertib) in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
Group 2 patients should have archived or fresh tumor tissue available from the non-craniotomy site and will have fresh tumor tissue available from the planned craniotomy
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970, berzosertib).
Patients with known diagnoses that are associated with germline DDR defects such as Li Fraumeni syndrome and ataxia telangiectasia are excluded from the study as M6620 (VX-970, berzosertib) is a DDR inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dosage of a new drug, berzosertib, when given with whole brain radiation therapy, for patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread to the brain.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include typical reactions from radiation like fatigue and hair loss, as well as possible effects from berzosertib such as nausea, vomiting, diarrhea, low blood counts increasing infection risk, and liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can provide tumor tissue from a surgery site other than the brain and will have fresh tissue from an upcoming brain surgery.
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My bilirubin levels are within the normal range for my condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to medications similar to M6620.
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I do not have genetic conditions like Li Fraumeni syndrome or ataxia telangiectasia.
Select...
I am not pregnant or breastfeeding.
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I do not have any serious ongoing illnesses or situations that would stop me from following the study's requirements.
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I do not have HIV or I am not on HIV medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With a Dose-limiting Toxicity
Secondary study objectives
Changes in Quality of Life
Incidence of Delayed Neurological Toxicity
Intracranial Progression-free Survival (icPFS)
+2 moreOther study objectives
Changes in Dynamic Susceptibility Contrast-magnetic Resonance Imaging Perfusion (Group I and II)
Mean Apparent Diffusion Coefficient in Diffusion-weighted Magnetic Resonance Imaging (Group I and II)
Pharmacokinetic Characteristics of M6620 (VX-970) (Group II)
Side effects data
From 2022 Phase 2 trial • 143 Patients • NCT0162286843%
Fatigue
33%
Headache
30%
Alopecia
25%
Nausea
19%
Anorexia
17%
Vomiting
17%
Memory impairment
16%
Pain
11%
Blurred vision
11%
Generalized muscle weakness
11%
Dizziness
11%
Dyspnea
11%
Peripheral sensory neuropathy
10%
Back pain
10%
Muscle weakness lower limb
8%
Anemia
8%
Constipation
8%
Diarrhea
8%
Paresthesia
6%
Abdominal pain
6%
Edema limbs
6%
Gait disturbance
6%
Hyperglycemia
6%
Cognitive disturbance
6%
Nervous system disorders - Other, specify
6%
Cough
5%
Weight loss
5%
Dry mouth
5%
Dyspepsia
5%
Lymphocyte count decreased
5%
Platelet count decreased
5%
Pain in extremity
5%
Depression
5%
Insomnia
5%
Skin and subcutaneous tissue disorders - Other, specify
5%
Skin hyperpigmentation
5%
Lymphedema
5%
Ataxia
5%
Dysgeusia
3%
Eye disorders - Other, specify
3%
Alanine aminotransferase increased
3%
Hypocalcemia
3%
Hyponatremia
3%
Musculoskeletal and connective tissue disorder - Other, specify
3%
Seizure
3%
Anxiety
3%
Confusion
3%
Dry skin
3%
Erythema multiforme
3%
Pruritus
3%
Hypertension
2%
Febrile neutropenia
2%
Cardiac arrest
2%
Ear pain
2%
Colonic obstruction
2%
Fever
2%
General disorders and administration site conditions - Other, specify
2%
Endocarditis infective
2%
Lung infection
2%
Alkaline phosphatase increased
2%
Dehydration
2%
Hyperkalemia
2%
Hypoalbuminemia
2%
Muscle weakness left-sided
2%
Intracranial hemorrhage
2%
Somnolence
2%
Hypoxia
2%
Pleural effusion
2%
Respiratory failure
2%
Nail loss
2%
Hypotension
2%
Thromboembolic event
2%
Vascular disorders - Other, specify
2%
Mucositis oral
2%
Urinary tract infection
2%
Dermatitis radiation
2%
Fall
2%
Aspartate aminotransferase increased
2%
Blood bilirubin increased
2%
White blood cell decreased
2%
Myalgia
2%
Dysarthria
2%
Palmar-plantar erythrodysesthesia syndrome
2%
Rash acneiform
2%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiation Therapy
Lapatinib and Radiation Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (VX-970, surgery, whole-brain radiation therapy)Experimental Treatment4 Interventions
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.
Group II: Group I (VX-970, whole-brain radiation therapy)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berzosertib
2021
Completed Phase 2
~80
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9890
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,936 Total Patients Enrolled
Pranshu MohindraPrincipal InvestigatorMayo Clinic Cancer Center LAO
1 Previous Clinical Trials
11 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications similar to M6620.I do not have genetic conditions like Li Fraumeni syndrome or ataxia telangiectasia.I am not taking strong CYP3A4 inhibitors or inducers, and can change my epilepsy medication if needed.You are expected to live for more than two months so that you can finish the study treatment and be checked for any harmful effects.I have a significant brain shift or bleeding but am stable after seizure treatment.I have lung cancer with brain metastases and am considering palliative brain radiation.Your white blood cell count is at least 3,000 per microliter.I have 1-3 small brain tumors, can move around, and my doctor recommends whole brain radiation.I do not have any serious ongoing illnesses or situations that would stop me from following the study's requirements.I do not have HIV or I am not on HIV medication.I've had recent cancer treatment but am mostly recovered from serious side effects.I haven't had whole brain radiation therapy before, but treatments like SRS/SRT are okay if done 2 weeks before.I am not pregnant or breastfeeding.I am taking 8 mg or less of dexamethasone daily as I start WBRT.I can care for myself but may not be able to do active work, or I have significant neurological issues but am deemed fit for treatment.I agree to use birth control during and up to 6 months after the study.Women who can have children must have a negative pregnancy test.I am 18 years old or older.Your absolute neutrophil count is at least 1,500 per microliter of blood.I can provide tumor tissue from a surgery site other than the brain and will have fresh tissue from an upcoming brain surgery.My kidney function, measured by creatinine levels, is normal or nearly normal.My bilirubin levels are within the normal range for my condition.You need to have at least 100,000 platelets per microliter of blood.Your liver enzymes are within a certain range, unless you have liver metastases, in which case they can be slightly higher.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (VX-970, whole-brain radiation therapy)
- Group 2: Group II (VX-970, surgery, whole-brain radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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