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NCT05168566

Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 99 → 128 participants
    • Trial sites expanded: 26 → 31 locations
    • Study sites revised (31)
  2. Eligibility criteria expanded, about 42 words
    • Enrollment target: 99 to 128
    • Study sites: 26 to 31
    • Publications: details revised at 1 of 1 entry
  3. Primary completion date: Jun 2026 to Dec 2027
    • Study completion date: Jun 2026 to Dec 2028
    • Study sites revised (26)
    v10
  4. Primary and study completion dates pushed to Jun 2026
    • Site details revised at 20 of 26 sites
    v9
  5. Study sites: 3 to 26v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 2 to 3v7
  2. Site details revised at 1 of 2 sitesv6
  3. Study sites: 1 to 2v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Feb 18, 2023 to Aug 2024
    • Study completion date: Mar 15, 2024 to Feb 2025
    • Start date changed from estimate of Jun 2022 to Sep 1, 2022
    • Site details revised
  5. Study sites: 0 to 1v3
  6. Start date: Mar 18, 2022 to Jun 2022
    • Collaborators shortened, about 2 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Assessment of Objective response rate (ORR)
Timeframe: 2 Years

Secondary (11)

Assessment of Duration of response (DoR)
Assessment of Disease control rate (DCR)
Assessment of Progression free survival (PFS)
Assessment of Time to progressive disease
Assessment of Time to response
Show 6 moreShow less
Assessment of Time to treatment failure (TTF)
Assessment of Overall survival (OS)
Assessment of 1-year progression-free survival
Assessment of 1-year survival
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)

Arms and interventions

Sutetinib Maleate ArmExperimental

Sutetinib capsules monotherapy

Drugs: Sutetinib Maleate Capsule

Sites

31 sites in 3 countries

China 20, United States 8, Australia 3