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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

The 50 most recent of 99 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 18, 2026 to Sep 17, 2027 Show 4 more changesShow less
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised at 3 of 9 sites
  2. Re-verified, no change to tracked fieldsv98
  3. Study completion date: Sep 22, 2025 to Sep 18, 2026v97
  4. Re-verified, no change to tracked fieldsv96
  5. Study completion date: Sep 22, 2024 to Sep 22, 2025v95
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv94
  2. Start date: Jul 21, 2016 to May 22, 2017
    • Study completion date: Feb 24, 2024 to Sep 22, 2024
    v93
  3. Re-verified, no change to tracked fieldsv92
  4. Results first posted: May 19, 2023
    • Primary endpoint revised
    • Secondary endpoints revised (5)
    v91
  5. Enrollment target: estimated 46 to confirmed 15
    • Primary completion date changed from estimate of Dec 30, 2023 to Aug 23, 2021
    • Study completion date: Dec 30, 2023 to Feb 24, 2024
    v90
  6. Primary and study completion dates: Dec 30, 2022 to Dec 30, 2023v89
  7. 3 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv86-v88
  8. Primary and study completion dates: Dec 30, 2021 to Dec 30, 2022v85
  9. Trial status: Recruiting to Active, Not Recruitingv84 Show 4 more changesShow less
    • Study completion date: Dec 30, 2021
    • Eligibility criteria expanded, about 56 words
    • Site details revised at 9 of 9 sites
    • Study description expanded, about 4 words
  10. Re-verified, no change to tracked fieldsv83
  11. Site details revised at 1 of 9 sitesv82
  12. Site details revised at 1 of 9 sitesv81
  13. Site details revised at 1 of 9 sitesv80
  14. Site details revised at 1 of 9 sitesv79
  15. Site details revised at 1 of 9 sitesv78
  16. Site details revised at 1 of 9 sitesv77
  17. Primary completion date: Dec 30, 2020 to Dec 30, 2021v76
  18. Site details revised at 1 of 9 sitesv75
  19. Site details revised at 1 of 9 sitesv74
  20. Site details revised at 2 of 9 sitesv73
  21. Re-verified, no change to tracked fieldsv72
  22. Site details revised at 1 of 9 sitesv71
  23. Eligibility criteria shortened, about 10 words
    • Study description revised
    • Site details revised at 1 of 9 sites
    v70
  24. Study sites revised (9)v69
  25. Re-verified, no change to tracked fieldsv68
  26. Site details revised at 1 of 9 sitesv67
  27. Site details revised at 1 of 9 sitesv66
  28. Site details revised at 1 of 9 sitesv65
  29. Site details revised at 2 of 9 sitesv64
  30. Site details revised at 2 of 9 sitesv63
  31. Re-verified, no change to tracked fieldsv62
  32. Primary endpoint revisedv61 Show 5 more changesShow less
    • Interventions: Berzosertib (Drug), Laboratory Biomarker Analysis (Other), Pharmacological Study (Other), Quality-of-Life Assessment (Other), Therapeutic… to Berzosertib (Drug), Quality-of-Life Assessment (Other), Therapeutic Conventional Surgery (Procedure), Whole-Brain Radiotherapy (Radiation)
    • Eligibility criteria expanded, about 236 words
    • Secondary endpoints revised (5)
    • Study description revised
    • Study title expanded, about 8 words
  33. Primary completion date: Jan 31, 2020 to Dec 30, 2020
    • Interventions: ATR Kinase Inhibitor M6620 (Drug), Laboratory Biomarker Analysis (Other), Pharmacological Study (Other), Quality-of-Life Assessment… to Berzosertib (Drug), Laboratory Biomarker Analysis (Other), Pharmacological Study (Other), Quality-of-Life Assessment (Other), Therapeutic…
    v60
  34. Site details revised at 1 of 9 sitesv59
  35. Primary completion date: Sep 30, 2019 to Jan 31, 2020v58
  36. Study sites: 8 to 9v57
  37. Site details revised at 1 of 8 sitesv56
  38. Site details revised at 1 of 8 sitesv55
  39. Site details revised at 1 of 8 sitesv54
  40. Primary completion date: Sep 30, 2018 to Sep 30, 2019
    • Site details revised at 2 of 8 sites
    v53
  41. Site details revised at 2 of 8 sitesv52
  42. Site contacts updated at 3 of 8 sitesv51
  43. Site details revised at 4 of 8 sitesv50
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02589522
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 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
Related terms Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Small Cell Lung Carcinoma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov