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

NCT05466149 Phase 2 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	Allist Pharmaceuticals, Inc.
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	100
Start date	2022-09-27
Completion	2026-12

Conditions

• NSCLC

Interventions

• Furmonertinib

Primary outcomes

• ORR, Objective Response Rate — Approximately 7.5 months following the last patient enrolled
  Percentage of patients with a confirmed CR or PR relative to the total number of patients.

Countries

China