Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Phase 3Active Not RecruitingNCT05607550

ArriVent BioPharma, Inc.398 enrolled

Overview

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

398

Conditions

Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing. * No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies). * Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months. * Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.

Outcomes

Primary Outcomes

Progression Free Survival (PFS) determined by blinded independent central review (BICR)

Time frame: Up to 32 months after first dose

Secondary Outcomes

Overall Survival (OS)

Time frame: Up to 62 months after first dose

PFS determined by investigator assessment

Time frame: Up to 36 months after first dose

Overall response rate (ORR)

Time frame: Up to 36 months after first dose

Duration of response (DOR)

Time frame: Up to 36 months after first dose

Time to second Progression Free Survival (PFS2)

Time frame: Up to 36 months after first dose

PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline

Time frame: Up to 36 months after first dose

Time to central nervous system (CNS) metastases by BICR