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A Phase I Study of CFT8919 in Patients With Advanced NSCLC

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Dec 9, 2025 → Jun 2027
See other at-risk trials from Betta Pharmaceuticals Co., Ltd.

Record History

  1. Primary completion pushed from Dec 9, 2025 to Jun 2027 Recruitment opened · Completion pushed from Apr 3, 2026 to Dec 2027 · Start date changed from estimate of Dec 13, 2024 to Nov 4, 2024 · 1 morev2 Show 4 more changesShow less
    • Recruitment opened
    • Completion pushed from Apr 3, 2026 to Dec 2027
    • Start date changed from estimate of Dec 13, 2024 to Nov 4, 2024
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are: * What is the maximum tolerated dose (MTD) of CFT8919? * Does CFT8919 demonstrate antitumor activity in these patients? Participants will: * Take CFT8919 capsules at different doses. * Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.
Trial Details
NCT Number NCT06641609
Lead Sponsor Betta Pharmaceuticals Co., Ltd.
Conditions Non-Small Cell Lung Cancer With EGFR Mutation
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov