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KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

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

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: May 31, 2024 to Dec 2027 Completion date: May 31, 2025 to Dec 2027 · Start date: Jun 16, 2022 to Jun 7, 2022v4 Show 2 more changesShow less
    • Completion date: May 31, 2025 to Dec 2027
    • Start date: Jun 16, 2022 to Jun 7, 2022
  3. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Trial status: Not Yet Recruiting to Active, Not Recruiting · Enrollment target: estimated 291 to confirmed 295 · Start date changed from estimate of Jun 1, 2022 to Jun 16, 2022 · 2 morev3 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 291 to confirmed 295
    • Start date changed from estimate of Jun 1, 2022 to Jun 16, 2022
    • Eligibility criteria shortened, about 19 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints revised (7) Study title shortened, about 9 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Trial Details
NCT Number NCT05294172
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Nasopharyngeal Carcinoma, Recurrent or Metastatic
Enrollment 295 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov