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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
Patients with a histologically confirmed diagnosis of non-small cell lung cancer (NSCLC), including neuroendocrine tumors or small cell lung cancer (SCLC) who are being evaluated for palliative WBRT (with or without neurosurgical resection or stereotactic radiosurgery [SRS]) for radiologically or histologically diagnosed brain metastases presumed to be from the lung cancer are eligible for this Phase I study. Group 2 will only include NSCLC patients.
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%). Note: though patients with ECOG performance status of 3 due to neurological deficits who are otherwise fit to receive systemic therapy per clinician assessments will be allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I have lung cancer with brain metastases and am considering palliative brain radiation.
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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.
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I agree to use birth control during and up to 6 months after the study.
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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 kidney function, measured by creatinine levels, is normal or nearly normal.
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My bilirubin levels are within the normal range for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Dose-limiting Toxicity
Secondary outcome measures
Changes in Quality of Life
Incidence of Delayed Neurological Toxicity
Intracranial Progression-free Survival (icPFS)
+2 more
Other outcome measures
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)
Pharmacodynamic Properties of pATR T1989, pCHK1 S345 and RAD51 in Cerebrospinal Fluid (CSF) Post-M6620 (VX-970) Administration (Group II)
+1 more

Side effects data

From 2022 Phase 2 trial • 143 Patients • NCT01622868
43%
Fatigue
33%
Headache
30%
Alopecia
25%
Nausea
19%
Anorexia
17%
Vomiting
17%
Memory impairment
16%
Pain
11%
Blurred vision
11%
Dizziness
11%
Generalized muscle weakness
11%
Dyspnea
11%
Peripheral sensory neuropathy
10%
Back pain
10%
Muscle weakness lower limb
8%
Constipation
8%
Diarrhea
8%
Anemia
8%
Paresthesia
6%
Abdominal pain
6%
Gait disturbance
6%
Edema limbs
6%
Cough
6%
Hyperglycemia
6%
Cognitive disturbance
6%
Nervous system disorders - Other, specify
5%
Dry mouth
5%
Platelet count decreased
5%
Dyspepsia
5%
Lymphocyte count decreased
5%
Weight loss
5%
Pain in extremity
5%
Insomnia
5%
Skin and subcutaneous tissue disorders - Other, specify
5%
Skin hyperpigmentation
5%
Lymphedema
5%
Ataxia
5%
Dysgeusia
5%
Depression
3%
Hypocalcemia
3%
Eye disorders - Other, specify
3%
Alanine aminotransferase increased
3%
Dry skin
3%
Erythema multiforme
3%
Pruritus
3%
Hypertension
3%
Hyponatremia
3%
Musculoskeletal and connective tissue disorder - Other, specify
3%
Seizure
3%
Anxiety
3%
Confusion
2%
Hypoalbuminemia
2%
Urinary tract infection
2%
Dermatitis radiation
2%
Febrile neutropenia
2%
Fall
2%
Dysarthria
2%
Palmar-plantar erythrodysesthesia syndrome
2%
Rash acneiform
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%
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%
Aspartate aminotransferase increased
2%
Blood bilirubin increased
2%
White blood cell decreased
2%
Myalgia
2%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiation Therapy
Lapatinib and Radiation Therapy

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
~9860
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,610 Previous Clinical Trials
40,915,791 Total Patients Enrolled
Pranshu MohindraPrincipal InvestigatorMayo Clinic Cancer Center LAO
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Berzosertib (M6620 [VX-970]) (ATR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02589522 — Phase 1
Brain Metastasis Research Study Groups: Group I (VX-970, whole-brain radiation therapy), Group II (VX-970, surgery, whole-brain radiation therapy)
Brain Metastasis Clinical Trial 2023: Berzosertib (M6620 [VX-970]) Highlights & Side Effects. Trial Name: NCT02589522 — Phase 1
Berzosertib (M6620 [VX-970]) (ATR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02589522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still ongoing for this experiment?

"The trial is not currently open for recruitment and has not been updated since July 16th, 2022. Alternatively, 6683 trials related to carcinoma, small cell are actively enrolling participants while 15 investigations centred around Whole-Brain Radiotherapy remain available."

Answered by AI

What hazards are associated with Whole-Brain Radiotherapy?

"Due to the limited existing data that supports its efficacy, Whole-Brain Radiotherapy has been given a score of 1 on our safety scale from 1 to 3."

Answered by AI

Are there any documented precedents of Whole-Brain Radiotherapy trials?

"Whole-Brain Radiotherapy was initially studied at the National Institutes of Health Clinical Centre in 2015, with 156 trials having been completed since then. Currently, 15 clinical trials are actively recruiting participants across Saint Louis, Missouri."

Answered by AI

What is the size of the cohort being monitored for this experiment?

"This research trial is no longer accepting new patients. It was initially posted on July 21st 2016 and the latest update occurred in July 16th 2022. If you are looking for other studies, 6683 trials recruiting participants with carcinoma small cell exist, as well as 15 investigations investigating Whole-Brain Radiotherapy that are still open to enrolment."

Answered by AI

In which locations has this research been implemented?

"Nine clinical trial sites are currently recruiting patients for this study, including Washington University School of Medicine in Saint Louis, the University of Kentucky/Markey Cancer Center in Lexington and Mayo Clinic in Rochester. Additionally there is a further six locations offering participation opportunities."

Answered by AI
~2 spots leftby Mar 2025