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Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date changed from estimate of Sep 2025 to Jun 27, 2025v4
  3. Primary completion date: Apr 2024 to Sep 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 2026 to Dec 2026
    • Site details revised
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2022 to Sep 27, 2022
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations. The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity. Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
Trial Details
NCT Number NCT05466149
Lead Sponsor Allist Pharmaceuticals, Inc.
Conditions
(from sponsor)		 NSCLC
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov