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A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 13 words Secondary endpoints: details revised at 5 of 21 entries · Site details revised at 11 of 63 sites · Study description expanded, about 5 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 5 of 21 entries
    • Site details revised at 11 of 63 sites
    • Study description expanded, about 5 words
  2. Primary completion date: Oct 31, 2025 to Dec 31, 2027 Completion date: Oct 31, 2026 to Dec 31, 2028 · Study sites revised (63) · Eligibility criteria shortened, about 3 wordsv34 Show 3 more changesShow less
    • Completion date: Oct 31, 2026 to Dec 31, 2028
    • Study sites revised (63)
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Interventions: NVL-520 (Drug) to Zidesamtinib (NVL-520) (Drug) Study title expanded, about 1 wordv33 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Site contacts updated at 1 of 63 sitesv32
  5. Study sites: 62 to 63v31
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites: 54 to 62v30
  2. Study sites: 44 to 54v29
  3. Study sites: 36 to 44v28
  4. Study sites: 34 to 36v27
  5. Study sites: 33 to 34v26
  6. Study sites: 32 to 33v25
  7. Study sites: 31 to 32v24
  8. Study sites: 29 to 31v23
  9. Study sites: 28 to 29v22
  10. Study sites: 26 to 28v21
  11. Primary endpoints revised (3) Enrollment target: 247 to 359 · Study sites: 21 to 26 · Eligibility criteria expanded, about 6 words · 2 morev20 Show 5 more changesShow less
    • Enrollment target: 247 to 359
    • Study sites: 21 to 26
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 17 to 21
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 20 to 21v19
  13. Study sites: 19 to 20v18
  14. Re-verified, no change to tracked fieldsv17
  15. Site contacts updated at 19 of 19 sitesv16
  16. Site details revised at 1 of 19 sitesv15
  17. Study sites: 17 to 19v14
  18. Study sites: 16 to 17v13
  19. Study sites: 15 to 16v12
  20. Study sites: 13 to 15v11
  21. Study sites: 12 to 13 Eligibility criteria shortened, about 2 wordsv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  22. Study sites: 11 to 12v9
  23. Enrollment target: 246 to 247 Study sites: 10 to 11 · Eligibility criteria expanded, about 12 wordsv8 Show 2 more changesShow less
    • Study sites: 10 to 11
    • Eligibility criteria expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  24. Re-verified, no change to tracked fieldsv7
  25. Study sites: 8 to 10v6
  26. Start date changed from estimate of Dec 2021 to Jan 4, 2022 Site details revised at 1 of 8 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 8 sites
  27. Study sites: 7 to 8v4
  28. Study sites: 6 to 7 Start date: Nov 2021 to Dec 2021v3 Show 1 more changeShow less
    • Start date: Nov 2021 to Dec 2021
  29. Site details revised at 1 of 6 sitesv2
  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.
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.
Trial Details
NCT Number NCT05118789
Lead Sponsor Nuvalent Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 359 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov