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Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Study acronym: ALKAZAR
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 158 to 159 Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 12 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 12 entries
  2. Study sites: 157 to 158v22
  3. Study sites: 156 to 157v21
  4. Study sites: 155 to 156v20
  5. Study sites: 153 to 155v19
  6. Trial sites expanded: 149 → 153 locationsv18
  7. Trial sites expanded: 137 → 149 locationsv17
  8. Study sites: 112 to 137v16
  9. Study sites: 98 to 112v15
  10. Study sites: 88 to 98v14
  11. Study sites: 70 to 88v13
  12. Study sites: 52 to 70v12
  13. Study sites: 36 to 52v11
  14. Study sites: 32 to 36v10
  15. Study sites: 29 to 32v9
  16. Study sites: 23 to 29v8
  17. Study sites: 20 to 23v7
  18. Study sites: 8 to 20v6
  19. Study sites: 7 to 8v5
  20. Start date changed from estimate of Mar 2025 to Jul 17, 2025 Study sites: 2 to 7 · Eligibility criteria shortened, about 14 wordsv4 Show 2 more changesShow less
    • Study sites: 2 to 7
    • Eligibility criteria shortened, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 1 to 2v3
  22. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: Oct 2029 to Dec 2029 · Start date: Jan 2025 to Mar 2025 · 4 morev2 Show 7 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Oct 2029 to Dec 2029
    • Start date: Jan 2025 to Mar 2025
    • Interventions: Alectinib (Drug), NVL-655 (Drug) to Alectinib (Drug), Neladalkib (NVL-655) (Drug)
    • Eligibility criteria revised
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  23. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
Trial Details
NCT Number NCT06765109
Lead Sponsor Nuvalent Inc.
Conditions Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov