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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

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

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: 4 to 7 Interventions: Neladalkib (NVL-655) (Drug) to Itraconazole (Drug), Midazolam (Drug), Neladalkib (NVL-655) (Drug), Repaglinide (Drug) · Eligibility criteria expanded, about 51 words · Secondary endpoints: 18 to 20 · 3 morev51 Show 6 more changesShow less
    • Interventions: Neladalkib (NVL-655) (Drug) to Itraconazole (Drug), Midazolam (Drug), Neladalkib (NVL-655) (Drug), Repaglinide (Drug)
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: 18 to 20
    • Study description expanded, about 63 words
    • Site contacts updated at 1 of 74 sites
    • Study arms: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (74)v50 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 470 to 840 Primary completion date: Feb 2026 to Dec 2027 · Study sites: 70 to 74 · Completion date: Mar 2026 to Jan 2028 · 3 morev49 Show 6 more changesShow less
    • Primary completion date: Feb 2026 to Dec 2027
    • Study sites: 70 to 74
    • Completion date: Mar 2026 to Jan 2028
    • Interventions: NVL-655 (Drug) to Neladalkib (NVL-655) (Drug)
    • Secondary endpoints revised (18)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 66 to 70v48
  5. Site contacts updated at 1 of 66 sitesv47
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 66 sitesv46
  2. Study sites: 65 to 66v45
  3. Study sites: 60 to 65v44
  4. Study sites: 54 to 60v43
  5. Study sites: 53 to 54v42
  6. Study sites: 50 to 53v41
  7. Site details revised at 4 of 50 sitesv40
  8. Study sites: 48 to 50v39
  9. Study sites: 47 to 48v38
  10. Site details revised at 2 of 47 sitesv37
  11. Site details revised at 1 of 47 sitesv36
  12. Study sites: 45 to 47v35
  13. Study sites: 39 to 45v34
  14. Study sites: 37 to 39v33
  15. Study sites: 32 to 37v32
  16. Study sites: 31 to 32v31
  17. Primary endpoints: 3 to 4 Enrollment target: 320 to 470 · Study sites: 25 to 31 · Eligibility criteria expanded, about 6 words · 3 morev30 Show 6 more changesShow less
    • Enrollment target: 320 to 470
    • Study sites: 25 to 31
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 17 to 18
    • Study description expanded, about 75 words
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  18. Site contacts updated at 1 of 25 sitesv29
  19. Enrollment target: 214 to 320v28
  20. Study sites: 24 to 25v27
  21. Study sites: 23 to 24v26
  22. Site contacts updated at 1 of 23 sitesv25
  23. Study sites: 22 to 23v24
  24. Study sites: 21 to 22v23
  25. Study sites: 20 to 21v22
  26. Study sites: 19 to 20v21
  27. Study sites: 18 to 19v20
  28. Study sites: 17 to 18v19
  29. Study sites: 16 to 17v18
  30. Study sites: 15 to 16v17
  31. Study sites: 14 to 15v16
  32. Re-verified, no change to tracked fieldsv15
  33. Study sites: 12 to 14v14
  34. Study sites: 11 to 12v13
  35. Site details revised at 1 of 11 sitesv12
  36. Study sites: 10 to 11v11
  37. Study sites: 7 to 10v10
  38. Site details revised at 1 of 7 sitesv9
  39. Site contacts updated at 7 of 7 sitesv8
  40. Site details revised at 2 of 7 sitesv7
  41. Site details revised at 1 of 7 sitesv6
  42. Study sites: 6 to 7v5
  43. Study sites: 5 to 6v4
  44. Study sites: 1 to 5 Start date changed from estimate of May 2022 to Jun 9, 2022v3 Show 1 more changeShow less
    • Start date changed from estimate of May 2022 to Jun 9, 2022
  45. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  • 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 neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib 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 neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC
Trial Details
NCT Number NCT05384626
Lead Sponsor Nuvalent Inc.
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 840 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov