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NCT02589522 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
15
Enrollment target
9
Study locations

NCT02589522: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).

NCT02589522 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (85% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02589522, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
9
Study locations

Study Summary

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.

Primary Outcome

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

Conditions Studied

Stage IV Lung Cancer AJCC v8 Metastatic Malignant Neoplasm in the Brain Metastatic Lung Non-Small Cell Carcinoma Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Metastatic Lung Small Cell Carcinoma Metastatic Lung Neuroendocrine Neoplasm

Interventions

  • OTHER Quality-of-Life Assessment
  • PROCEDURE Therapeutic Conventional Surgery
  • DRUG Berzosertib
  • RADIATION Whole-Brain Radiotherapy

Study Locations (9)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • University of California Davis Comprehensive Cancer Center - Sacramento

Maryland

  • University of Maryland/Greenebaum Cancer Center - Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Florida

  • Mayo Clinic in Florida - Jacksonville

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Minnesota

  • Mayo Clinic in Rochester - Rochester

Missouri

  • Washington University School of Medicine - St Louis

Ohio

  • Case Western Reserve University - Cleveland

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-05-22
Est. Completion 2026-09-18
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02589522 still lists

NCT02589522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (85% lower).

The record links to 7 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.

NCT02589522 lists 9 locations in 7 states (California, Maryland, Florida).

Frequently Asked Questions

What is clinical trial NCT02589522 about?

NCT02589522 is a clinical study titled "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". 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...

What is the current status of trial NCT02589522?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-05-22. Estimated completion is 2026-09-18.

What conditions does trial NCT02589522 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8.

What interventions are being tested in trial NCT02589522?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Berzosertib (DRUG), Whole-Brain Radiotherapy (RADIATION).

Who is sponsoring clinical trial NCT02589522?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02589522 being conducted?

This trial has 9 study locations across California, Florida, Kentucky, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02589522's enrollment target sits among peer trials

15 68th of 81 higher than 12 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02589522, the US trial registry maintained by the National Library of Medicine. NCT02589522 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.