ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

StatusUnknown
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Active, Not Recruiting
  2. Notable Primary completion date changed from estimate of Mar 30, 2023 to Mar 31, 2024v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 334 to confirmed 337
    • Study completion date: Dec 30, 2023 to Sep 30, 2026
    • Eligibility criteria expanded, about 710 words
    • Site details revised at 3 of 3 sites
  3. Notable Primary completion date: Jan 2021 to Mar 30, 2023
    • Study completion date: Aug 2021 to Dec 30, 2023
    • Eligibility criteria shortened, about 19 words
    v3
  4. Minor Interventions: ASK120067 + placebo (Drug), Gefitinib + placebo ASK120067 (Drug), Gefitinib 250 mg (Drug), Placebo ASK120067 (Drug), Placebo Gefitinib 250… to ASK120067 (Drug), Gefitinib (Drug), Placebo ASK120067 (Drug), Placebo Gefitinib 250 mg (Drug)
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 1 of 3 sites
    • Study title shortened, about 1 word
    v2
  5. Minor Study First Submitted
  • 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.
To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
Trial Details
NCT Number NCT04143607
Lead Sponsor Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Conditions
(from sponsor)
Locally Advanced or Metastatic NSCLC
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 337 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov