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 3

Recruiting

• Conditions: Metastatic Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; EGFR Exon 20 Mutations
• Interventions: Drug: furmonertinib 240 mg oral, daily; Drug: furmonertinib 160 mg oral, daily; Drug: platinum-based chemotherapy

• Registration Number: NCT05607550
• Lead Sponsor: ArriVent BioPharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-07
• Study Start: 2023-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-08-15
• Study Completion: 2028-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
furmonertinib 240 mg	furmonertinib 240 mg oral, daily	-
furmonertinib 160 mg	furmonertinib 160 mg oral, daily	-
platinum-based chemotherapy	platinum-based chemotherapy	carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) determined by blinded independent central review (BICR)	Up to 32 months after first dose

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	Up to 36 months after first dose
Time to second Progression Free Survival (PFS2)	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	Up to 36 months after first dose
CNS ORR evaluated by BICR	Randomization up to ≤30 days after last dose
Overall Survival (OS)	Up to 62 months after first dose
PFS determined by investigator assessment	Up to 36 months after first dose
Overall response rate (ORR)	Up to 36 months after first dose
Time to central nervous system (CNS) metastases by BICR	Randomization up to ≤30 days after last dose
CNS DOR evaluated by BICR	Randomization up to ≤30 days after last dose
CNS PFS evaluated by BICR	Randomization up to ≤30 days after last dose
Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)	Randomization up to ≤30 days after last dose	NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib	Up to 36 months after first dose
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)	Randomization up to ≤30 days after last dose	QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)	Randomization up to ≤30 days after last dose	QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.
Plasma concentrations of furmonertinib and its major metabolite (AST5902)	Up to 36 months after first dose

Trial Locations

Locations (4)

Arrivent Investigative Site; 🇬🇧 Bebington, Wirral, United Kingdom

Arrivent Investigative site; 🇺🇸 Sacramento, California, United States

ArriVent Investigative Site; 🇬🇧 Sutton, United Kingdom

Allist Investigative Site; 🇨🇳 Zhengzhou, China