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A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Collaborators shortened, about 5 wordsv6 Show 1 more changeShow less
    • Collaborators shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 356 to confirmed 376 · Primary completion date changed from estimate of May 20, 2025 to Jul 11, 2024 · Site details revisedv5 Show 3 more changesShow less
    • Enrollment target: estimated 356 to confirmed 376
    • Primary completion date changed from estimate of May 20, 2025 to Jul 11, 2024
    • Site details revised
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 20, 2023 to Jun 26, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 20, 2023 to Jun 26, 2023
  6. Secondary endpoints: 8 to 9v2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
Trial Details
NCT Number NCT05870319
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 376 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov