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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)

Primary Purpose

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

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

furmonertinib 240 mg oral, daily

furmonertinib 160 mg oral, daily

platinum-based chemotherapy

About this trial

This is an interventional treatment trial for Metastatic Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer (NSCLC), Exon 20, Furmonertinib, FURMO-004, Drug-Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 validated results confirming 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 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

furmonertinib 240 mg

furmonertinib 160 mg

platinum-based chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)

PFS determined by investigator assessment

Overall response rate (ORR)

Duration of response (DOR)

Time to second Progression Free Survival (PFS2)

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

Time to central nervous system (CNS) metastases by BICR

CNS ORR evaluated by BICR

CNS DOR evaluated by BICR

CNS PFS evaluated by BICR

Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)

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)

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.

Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)

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

Plasma concentrations of furmonertinib and its major metabolite (AST5902)

Full Information

NCT ID

NCT05607550

First Posted

October 31, 2022

Last Updated

October 21, 2023

Sponsor

ArriVent BioPharma, Inc.

Collaborators

Allist Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05607550

Brief Title

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)

Official Title

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

August 15, 2025 (Anticipated)

Study Completion Date

February 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ArriVent BioPharma, Inc.

Collaborators

Allist Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Non-Small Cell Lung Cancer (NSCLC), Exon 20, Furmonertinib, FURMO-004, Drug-Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

furmonertinib 240 mg

Arm Type

Experimental

Arm Title

furmonertinib 160 mg

Arm Type

Experimental

Arm Title

platinum-based chemotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

furmonertinib 240 mg oral, daily

Other Intervention Name(s)

AST2818

Intervention Description

furmonertinib tablet

Intervention Type

Drug

Intervention Name(s)

furmonertinib 160 mg oral, daily

Other Intervention Name(s)

AST2818

Intervention Description

furmonertinib tablet

Intervention Type

Drug

Intervention Name(s)

platinum-based chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 32 months after first dose

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

Up to 62 months after first dose

Title

PFS determined by investigator assessment

Time Frame

Up to 36 months after first dose

Title

Overall response rate (ORR)

Time Frame

Up to 36 months after first dose

Title

Duration of response (DOR)

Time Frame

Up to 36 months after first dose

Title

Time to second Progression Free Survival (PFS2)

Time Frame

Up to 36 months after first dose

Title

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

Title

Time to central nervous system (CNS) metastases by BICR

Time Frame