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Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Apr 30, 2026 to Aug 31, 2026v46
  2. Minor Re-verified, no change to tracked fieldsv45
  3. Minor Study sites: 177 to 176 Completion date: Oct 31, 2025 to Apr 30, 2026v44 Show 1 more changeShow less
    • Completion date: Oct 31, 2025 to Apr 30, 2026
  4. Minor Re-verified, no change to tracked fieldsv43
  5. Minor Completion date: Feb 20, 2025 to Oct 31, 2025v42
Show 40 earlier versionsHide 40 earlier versions
  1. Notable Results first posted: Jun 9, 2023 Primary endpoints: 1 to 3 · Study sites: 149 to 177 · Eligibility criteria revised · 3 morev41 Show 6 more changesShow less
    • Primary endpoints: 1 to 3
    • Study sites: 149 to 177
    • Eligibility criteria revised
    • Secondary endpoints: 15 to 14
    • Study description revised
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study sites: 141 to 149v40
  3. Minor Re-verified, no change to tracked fieldsv39
  4. Minor Primary completion date changed from estimate of Feb 20, 2022 to May 16, 2022v38
  5. Minor Primary completion date: Dec 9, 2021 to Feb 20, 2022 Completion date: Feb 28, 2023 to Feb 20, 2025v37 Show 1 more changeShow less
    • Completion date: Feb 28, 2023 to Feb 20, 2025
  6. Minor Re-verified, no change to tracked fieldsv36
  7. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 330 to confirmed 337 · Study sites: 151 to 141v35 Show 2 more changesShow less
    • Enrollment target: estimated 330 to confirmed 337
    • Study sites: 151 to 141
  8. Minor Re-verified, no change to tracked fieldsv34
  9. Minor Study title shortened, about 3 wordsv33 See this version in full on ClinicalTrials.gov ↗
  10. Minor Study sites: 136 to 151v32
  11. Minor 3 versions Re-verified since Nov 20, 2020, no change to tracked fieldsv29-v31
  12. Minor Site details revised at 63 of 136 sitesv28
  13. Minor Re-verified, no change to tracked fieldsv27
  14. Minor Enrollment target: 280 to 330 Publications: details revised at 1 of 7 entriesv26 Show 1 more changeShow less
    • Publications: details revised at 1 of 7 entries
  15. Minor Re-verified, no change to tracked fieldsv25
  16. Minor Study sites: 97 to 136v24
  17. Minor Eligibility criteria expanded, about 14 words Secondary endpoints revised (15)v23 Show 1 more changeShow less
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  18. Minor Secondary endpoints: 16 to 15v22 See this version in full on ClinicalTrials.gov ↗
  19. Minor Eligibility criteria expanded, about 3 wordsv21 See this version in full on ClinicalTrials.gov ↗
  20. Minor 2 versions Re-verified since Dec 13, 2019, no change to tracked fieldsv19-v20
  21. Notable Enrollment target: 120 to 280 Primary completion date: Jun 25, 2019 to Dec 9, 2021 · Completion date: Dec 31, 2019 to Feb 28, 2023 · Eligibility criteria revised · 1 morev18 Show 4 more changesShow less
    • Primary completion date: Jun 25, 2019 to Dec 9, 2021
    • Completion date: Dec 31, 2019 to Feb 28, 2023
    • Eligibility criteria revised
    • Study description expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  22. Minor Eligibility criteria revised Study sites revised (97)v17 Show 1 more changeShow less
  23. Minor Study sites: 94 to 97v16
  24. Minor Study sites: 90 to 94v15
  25. Minor Study sites: 93 to 90 Interventions: tepotinib (Drug) to Tepotinib (Drug) · Eligibility criteria shortened, about 99 words · Secondary endpoints revised (16) · 1 morev14 Show 4 more changesShow less
    • Interventions: tepotinib (Drug) to Tepotinib (Drug)
    • Eligibility criteria shortened, about 99 words
    • Secondary endpoints revised (16)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  26. Notable Enrollment target: 60 to 120v13
  27. Notable Enrollment target: 120 to 60 Primary completion date: Jun 30, 2019 to Jun 25, 2019 · Study sites revised (93)v12 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2019 to Jun 25, 2019
    • Study sites revised (93)

    See this version in full on ClinicalTrials.gov ↗

  28. Minor Study sites: 92 to 93v11
  29. Minor Site details revised at 3 of 92 sitesv10
  30. Minor Site details revised at 2 of 92 sitesv9
  31. Minor Re-verified, no change to tracked fieldsv8
  32. Notable Primary completion date: Dec 31, 2018 to Jun 30, 2019v7
  33. Minor Study sites: 36 to 92v6
  34. Notable Enrollment target: 60 to 120 Primary completion date: Mar 2018 to Dec 31, 2018 · Completion date: Sep 2018 to Dec 31, 2019 · Start date: Sep 2016 to Sep 13, 2016 · 3 morev5 Show 6 more changesShow less
    • Primary completion date: Mar 2018 to Dec 31, 2018
    • Completion date: Sep 2018 to Dec 31, 2019
    • Start date: Sep 2016 to Sep 13, 2016
    • Eligibility criteria shortened, about 50 words
    • Site details revised at 6 of 36 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  35. Minor Re-verified, no change to tracked fieldsv4
  36. Notable Start date: Jul 2016 to Sep 2016 Study sites: 18 to 36 · Eligibility criteria expanded, about 230 words · Secondary endpoints: 15 to 16v3 Show 3 more changesShow less
    • Study sites: 18 to 36
    • Eligibility criteria expanded, about 230 words
    • Secondary endpoints: 15 to 16

    See this version in full on ClinicalTrials.gov ↗

  37. Minor Study sites: 2 to 18v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.
Trial Details
NCT Number NCT02864992
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IV
Enrollment 337 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov