furmonertinib 240 mg for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Small Cell Lung Cancer+13 Morefurmonertinib 240 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 NSCLC with 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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Chemotherapy
  • Non-Small-Cell Lung Carcinoma
  • Tumors
  • Lung Cancer
  • Bronchial Tumors
  • Lung Disease
  • Respiratory Diseases
  • Enzyme Inhibitors
  • Molecular Pharmacology
  • Protein Kinase Inhibitors

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Randomization up to ≤30 days after last dose

Day 30
Central Nervous System
CNS ORR evaluated by BICR
Central Nervous System
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
Malignant Neoplasms
Time to central nervous system (CNS) metastases by BICR
Month 32
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Month 36
Duration of response (DOR)
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Heart rate
Brain
PFS determined by investigator assessment
Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time to second Progression Free Survival (PFS2)
Month 62
Overall Survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

platinum-based chemotherapy
1 of 3
furmonertinib 240 mg
1 of 3
furmonertinib 160 mg
1 of 3

Active Control

Experimental Treatment

375 Total Participants · 3 Treatment Groups

Primary Treatment: furmonertinib 240 mg · No Placebo Group · Phase 3

furmonertinib 240 mg
Drug
Experimental Group · 1 Intervention: furmonertinib 240 mg · Intervention Types: Drug
furmonertinib 160 mg
Drug
Experimental Group · 1 Intervention: furmonertinib 160 mg · Intervention Types: Drug
platinum-based chemotherapy
Drug
ActiveComparator Group · 1 Intervention: platinum-based chemotherapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: randomization up to ≤30 days after last dose

Who is running the clinical trial?

ArriVent BioPharma, Inc.Lead Sponsor
1 Previous Clinical Trials
170 Total Patients Enrolled
Allist Pharmaceuticals, Inc.Industry Sponsor
14 Previous Clinical Trials
1,600 Total Patients Enrolled
Morgan LamStudy DirectorArriVent BioPharm
3 Previous Clinical Trials
370 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a non-squamous NSCLC that is not amenable to curative surgery or radiotherapy.
You have a documented mutation in tumor tissue or blood from local or central testing.
You have not received prior systemic anticancer therapy for locally advanced or metastatic NSCLC.
You have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemoradiotherapy for non-metastatic disease.
You have a history of treated CNS metastases or new asymptomatic CNS metastases.