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Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Record History

  1. Primary and study completion pushed from Jul 2026 to Jul 2027v36
  2. 3 versions Re-verified since Jun 24, 2024, no change to tracked fieldsv33-v35
  3. Primary and study completion dates: Jul 2023 to Jul 2026v32
  4. Primary and study completion dates: Jul 2022 to Jul 2023v31
  5. Eligibility criteria expanded, about 4 wordsv30 See this version in full on ClinicalTrials.gov ↗
Show 28 earlier versionsHide 28 earlier versions
  1. Primary and study completion dates: Jul 2021 to Jul 2022 Enrollment target: 68 to 86 · Eligibility criteria expanded, about 8 words · Secondary endpoints revised (5)v29 Show 3 more changesShow less
    • Enrollment target: 68 to 86
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  2. 3 versions Re-verified since Feb 5, 2020, no change to tracked fieldsv26-v28
  3. Primary and study completion dates: Jul 2020 to Jul 2021 Study sites: 8 to 7v25 Show 1 more changeShow less
    • Study sites: 8 to 7
  4. Site details revised at 1 of 8 sitesv24
  5. Primary and study completion dates: Jul 2019 to Jul 2020 Study sites: 7 to 8v23 Show 1 more changeShow less
    • Study sites: 7 to 8
  6. Re-verified, no change to tracked fieldsv22
  7. Study sites: 6 to 7v21
  8. Eligibility criteria expanded, about 30 wordsv20 See this version in full on ClinicalTrials.gov ↗
  9. Re-verified, no change to tracked fieldsv19
  10. Primary and study completion dates: Jul 2018 to Jul 2019 Site details revised at 1 of 6 sitesv18 Show 1 more changeShow less
    • Site details revised at 1 of 6 sites
  11. Primary and study completion dates: Jul 2017 to Jul 2018 Study sites: 5 to 6v17 Show 1 more changeShow less
    • Study sites: 5 to 6
  12. Study sites: 6 to 5 Eligibility criteria expanded, about 42 wordsv16 Show 1 more changeShow less
    • Eligibility criteria expanded, about 42 words

    See this version in full on ClinicalTrials.gov ↗

  13. Primary and study completion dates: Jul 2016 to Jul 2017v15
  14. Re-verified, no change to tracked fieldsv14
  15. Enrollment target: 50 to 68 Eligibility criteria shortened, about 11 words · Secondary endpoints revised (5) · Site contacts updated at 1 of 6 sitesv13 Show 3 more changesShow less
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints revised (5)
    • Site contacts updated at 1 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv12
  17. Primary and study completion dates: Jul 2015 to Jul 2016 Study sites: 5 to 6v11 Show 1 more changeShow less
    • Study sites: 5 to 6
  18. Study sites revised (5)v10 See this version in full on ClinicalTrials.gov ↗
  19. Enrollment target: 25 to 50 Primary endpoints: 1 to 2 · Eligibility criteria expanded, about 76 words · Secondary endpoints: 3 to 5 · 1 morev9 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 76 words
    • Secondary endpoints: 3 to 5
    • Study title expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  20. 3 versions Re-verified since Feb 26, 2014, no change to tracked fieldsv6-v8
  21. Eligibility criteria shortened, about 237 words Study title revisedv5 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  22. Site contacts updated at 5 of 5 sitesv4
  23. Re-verified, no change to tracked fieldsv3
  24. Eligibility criteria expanded, about 11 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. 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.
The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity. A phase II study looks at how effective a medication is at treating a specific type of cancer and collects information on the side effects of the study treatment. RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In addition, this drug interferes with other cell pathways that also cause cancer cells to grow, form new blood vessels, and spread to other organs of the body. The goal of using cabozantinib is to shrink the cancer and to prevent it from growing Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects it causes and can anticipate them.
Trial Details
NCT Number NCT01639508
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Exelixis
Conditions Non-Small Cell Lung Cancer
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov