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NCT06862869

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Roche/Genentech

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Record History

All 22 versions: 19 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
    • Site details revised at 5 of 44 sites
  2. Primary completion pushed from Oct 30, 2028 to Oct 30, 2029
    • Study completion pushed from Apr 30, 2029 to Feb 28, 2030
    v20
  3. Study sites: 43 to 44v18
  4. Study sites: 41 to 43v17
  5. Study sites: 40 to 41v16
  6. Trial sites expanded: 36 → 40 locationsv15
  7. Study sites: 35 to 36v14
  8. Study sites: 32 to 35
    • Primary completion date: Jun 30, 2029 to Oct 30, 2028
    • Study completion date: Dec 31, 2029 to Apr 30, 2029
    v13
  9. Study sites: 27 to 32v12
  10. Study sites: 20 to 27v11
  11. Study sites: 18 to 20
    • Study completion date: Nov 30, 2029 to Dec 31, 2029
    v10
  12. Study sites: 17 to 18v9
  13. Study sites: 14 to 17v8
  14. Start date: Mar 26, 2025 to Apr 30, 2025
    • Study sites: 11 to 14
    • Primary completion date: Mar 30, 2029 to Jun 30, 2029
    • Study completion date: Mar 30, 2029 to Nov 30, 2029
    v7
  15. Study sites: 8 to 11v6
  16. Study sites: 3 to 8v5
  17. Study sites: 1 to 3v4
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 15, 2025 to Mar 26, 2025
    v2
  19. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Real-world disease-free survival (rwDFS)
Timeframe: From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)

Secondary (6)

Duration of alectinib therapy
Participant demographics by disease stage and city tier
Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier
Participant clinical characteristics as determined by surgery history by disease stage and city tier
Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires
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Incidence and severity of adverse events (AEs)

Arms and interventions

Cohort 1

Participants with resected stage II-IIIB ALK-positive NSCLC who have received Alectinib adjuvant therapy will be followed-up for approximately 2.5 years during routine visits at real-world clinical practice settings.

Drugs: Alectinib

Sites

44 sites in 1 country