Trial · NCT02589522

Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors

NCT02589522, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-05-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors. Trials, record NCT02589522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02589522

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors
NCT number: NCT02589522
Status: Active not recruiting
Phases: Phase 1
Enrollment: 15 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Metastatic Lung Neuroendocrine Neoplasm, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Interventions: Berzosertib, Quality-of-Life Assessment, Therapeutic Conventional Surgery, Whole-Brain Radiotherapy
First posted: 2015-10-28
Last updated: 2026-10-14
Results first posted: 2023-05-19

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Dose-limiting Toxicity	Up to 3 weeks after completing whole brain radiotherapy (WBRT)	Defined as any grade 3 or more non-hematological toxicity requiring more than 5 day interruption in therapy or any grade 4 or higher hematological toxicity that is attributable to the berzosertib (M6620 \[VX-970\]) and/or whole brain radiotherapy
Secondary	Incidence of Delayed Neurological Toxicity	Up to 6-months post-completion of WBRT	Assessed using Hopkins Verbal Learning Test-Revised. Incidence of events will be expressed as proportions with exact 95% confidence limits.
Secondary	Changes in Quality of Life	Baseline to up to 6 months post-completion of WBRT	Measured by the Functional Assessment of Cancer Therapy-Brain. Descriptive statistics of the actual change scores will also be provided. The median change score and quartiles will be reported. Where relevant the proportion of patients experiencing a clinically significant change in score will be reported with 95% confidence limits.
Secondary	Radiological Response Rate	6 months	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is \>=30% decrease in the sum of the target lesions; Disease Progression (PD) is \>= 20% increase in the smallest sum of the target lesions; Stable Disease (SD) is between PR and PD.
Secondary	Intracranial Progression-free Survival (icPFS)	6 months	Kaplan-Meier estimates of median icPFS will be calculated. Patients alive without intracranial progression at last follow-up will be censored at the date of the last radiologic assessment.
Secondary	Overall Survival (OS)	12 months	Kaplan-Meier estimates of OS will be calculated. For calculation of OS, patients alive at last follow-up will be censored. Exploratory Cox regression analysis with M6620 (VX-970) dose as a covariate will be performed.
Other	Changes in Dynamic Susceptibility Contrast-magnetic Resonance Imaging Perfusion (Group I and II)	Baseline to up to 12 months	Descriptive statistics of the actual change scores will also be provided. The median change score and quartiles will be reported. Where relevant the proportion of patients experiencing a clinically significant change in score will be reported with 95% confidence limits.
Other	Pharmacokinetic Characteristics of M6620 (VX-970) (Group II)	During surgery, pre-dose, and 2 hours and 50 minutes after start of M6620 (VX-970) infusion	Pharmacokinetics of the presence of M6620 (VX-970) in blood, CSF, and tissue will be assessed.
Other	Pharmacodynamic Properties of pATR T1989, pCHK1 S345 and RAD51 in Cerebrospinal Fluid (CSF) Post-M6620 (VX-970) Administration (Group II)	At 3 weeks post completion of WBRT
Other	Mean Apparent Diffusion Coefficient in Diffusion-weighted Magnetic Resonance Imaging (Group I and II)	Up to 12 months	Descriptive statistics of the actual change scores will be provided.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Dose-limiting Toxicity	Up to 3 weeks after completing whole brain radiotherapy (WBRT)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Delayed Neurological Toxicity	Up to 6-months post-completion of WBRT	Not collected
SECONDARY	Changes in Quality of Life	Baseline to up to 6 months post-completion of WBRT	Not collected
SECONDARY	Radiological Response Rate	6 months	Study was closed before enrolling to Group 2.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intracranial Progression-free Survival (icPFS)	6 months	Not collected.
SECONDARY	Overall Survival (OS)	12 months	Study was closed before enrolling to Group 2.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Changes in Dynamic Susceptibility Contrast-magnetic Resonance Imaging Perfusion (Group I and II)	Baseline to up to 12 months	Not collected
OTHER_PRE_SPECIFIED	Pharmacokinetic Characteristics of M6620 (VX-970) (Group II)	During surgery, pre-dose, and 2 hours and 50 minutes after start of M6620 (VX-970) infusion	Not collected.
OTHER_PRE_SPECIFIED	Pharmacodynamic Properties of pATR T1989, pCHK1 S345 and RAD51 in Cerebrospinal Fluid (CSF) Post-M6620 (VX-970) Administration (Group II)	At 3 weeks post completion of WBRT	Not collected
OTHER_PRE_SPECIFIED	Mean Apparent Diffusion Coefficient in Diffusion-weighted Magnetic Resonance Imaging (Group I and II)	Up to 12 months	Not collected

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With a Dose-limiting Toxicity	Group 1 - Dose Level 1	Experiencing a dose limiting toxicity	2	Participants
Number of Participants With a Dose-limiting Toxicity	Group 1 - Dose Level 2	Experiencing a dose limiting toxicity	0	Participants
Number of Participants With a Dose-limiting Toxicity	Group 1 - Dose Level 1	Not experiencing a dose limiting toxicity	7	Participants
Number of Participants With a Dose-limiting Toxicity	Group 1 - Dose Level 2	Not experiencing a dose limiting toxicity	2	Participants
Radiological Response Rate	Group 1 - Dose Level 1	Complete response	0	Participants
Radiological Response Rate	Group 1 - Dose Level 2	Complete response	0	Participants
Radiological Response Rate	Group 1 - Dose Level 1	Partial response	0	Participants
Radiological Response Rate	Group 1 - Dose Level 2	Partial response	0	Participants
Radiological Response Rate	Group 1 - Dose Level 1	Stable disease	3	Participants
Radiological Response Rate	Group 1 - Dose Level 2	Stable disease	0	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 - Dose Level 1	11
Overall Study	STARTED	Group 1 - Dose Level 2	4
Overall Study	STARTED	Group 2	0
Overall Study	COMPLETED	Group 1 - Dose Level 1	9
Overall Study	COMPLETED	Group 1 - Dose Level 2	2
Overall Study	COMPLETED	Group 2	0
Overall Study	NOT COMPLETED	Group 1 - Dose Level 1	2
Overall Study	NOT COMPLETED	Group 1 - Dose Level 2	2
Overall Study	NOT COMPLETED	Group 2	0

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Agitation	Psychiatric disorders	Group 1 - Dose Level 1	1	9	1
other	Agitation	Psychiatric disorders	Group 1 - Dose Level 2	0	2
other	Alkaline phosphatase increased	Investigations	Group 1 - Dose Level 1	1	9	3
other	Alkaline phosphatase increased	Investigations	Group 1 - Dose Level 2	0	2
other	Alopecia	Skin and subcutaneous tissue disorders	Group 1 - Dose Level 1	2	9	2
other	Alopecia	Skin and subcutaneous tissue disorders	Group 1 - Dose Level 2	0	2
other	Anemia	Blood and lymphatic system disorders	Group 1 - Dose Level 1	2	9	6
other	Anemia	Blood and lymphatic system disorders	Group 1 - Dose Level 2	0	2
other	Anorexia	Metabolism and nutrition disorders	Group 1 - Dose Level 1	1	9	2
other	Anorexia	Metabolism and nutrition disorders	Group 1 - Dose Level 2	1	2	1

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 - Dose Level 1	7	9
Total, all-cause mortality	Group 1 - Dose Level 2	0	2
Total, other adverse events	Group 1 - Dose Level 1	9	9
Total, other adverse events	Group 1 - Dose Level 2	2	2
Total, serious adverse events	Group 1 - Dose Level 1	5	9
Total, serious adverse events	Group 1 - Dose Level 2	0	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants4

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
UM1CA186644	North American Star Consortium	BEDARD, PHILIPPE; COURTNEY, KEVIN D; GRANT, STEVEN; LANCET, JEFFREY; MAHALINGAM, DEVALINGAM; SIU, LILLIAN L	UNIVERSITY HEALTH NETWORK	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER
UM1CA186690	NCI ETCTN Pittsburgh Cancer Consortium (PCC)	VILLARUZ, LIZA COSCA; BYRD, JOHN C.; DAYYANI, FARSHID	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER
UM1CA186691	The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies	CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER
UM1CA186686	NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis	ADJEI, ALEX A.	MAYO CLINIC ROCHESTER	NATIONAL CANCER INSTITUTE	2014 to 2019	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group 1 - Dose Level 1 vs Group 1 - Dose Level 2: deaths from any cause	Trial comparisons
Group 1 - Dose Level 1 vs Group 1 - Dose Level 2: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Learning	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02589522

GET https://conductscience.org/api/trials/v1/NCT02589522/events?page=2

API reference For AI assistants