Trial intelligence / Profile preview

High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutated NSCLC

NCT06652048Phase 2

Key facts

Status
Recruiting
Start
Oct 2024
Primary completion
Dec 2026
Countries
1
Modality
Small Molecules
Conditions
non-small cell lung cancer (NSCLC)
01

Overview

Phase 2, randomised, open-label trial of furmonertinib in non-small cell lung cancer (NSCLC) (3 arms). Primary endpoint: Progression-free survival at 2 years. Started Oct 2024; status: recruiting.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Furmonertinib 160mg

    Furmonertinib 160mg p.o qd.

  • Furmonertinib 240mg

    Furmonertinib 240mg p.o qd.

  • Furmonertinib 160mg + Chemo

    Furmonertinib 160mg p.o qd + Carboplatin/Cisplatin + Pemetrexed followed by Pemetrexed maintenance.

03

Who it enrols

Patients with locally advanced or metastatic NSCLC with EGFR-sensitive mutations who progressed on first-line third-generation EGFR-TKI monotherapy.

04

Endpoints

Primary

  • Progression-free survival

Secondary

  • Disease Control Rate

  • Objective Response Rate

  • Duration of Response

  • Overall Survival

  • Time to Subsequent Therapy

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