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)

ArriVent BioPharma

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: platinum-based chemotherapy; Drug: furmonertinib 240 mg oral, daily; Drug: furmonertinib 160 mg oral, daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607550

FURMO-004

2022-502977-41-00

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 3 patient groups

furmonertinib 240 mg

Experimental group

Treatment:

Drug: furmonertinib 240 mg oral, daily

furmonertinib 160 mg

Experimental group

Treatment:

Drug: furmonertinib 160 mg oral, daily

platinum-based chemotherapy

Active Comparator group

Description:

carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Treatment:

Drug: platinum-based chemotherapy