Furmonertinib for Respiratory Tract Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ArriVent Investigative Site, Orlando, FL
Respiratory Tract Neoplasms+15 More
Furmonertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1b, open-label, multi-center, dose-escalation and dose-expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations. Patients will be enrolled into 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

Eligible Conditions

  • Respiratory Tract Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Respiratory Tract Diseases
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasms by Site
  • Protein Kinase Inhibitors
  • Thoracic Neoplasms
  • Bronchial Neoplasms
  • Carcinoma, Bronchogenic
  • Antineoplastic Agents
  • Lung Diseases
  • Enzyme Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 36 months after first dose

Month 36
Central Nervous System (CNS) DOR
Central Nervous System (CNS) ORR
Duration of Response (DOR)
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Overall Response Rate (ORR)
Overall survival
Progression Free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Stage 2 Expansion Cohort 3
1 of 4
Stage 1 Dose Escalation and Backfill
1 of 4
Stage 2 Expansion Cohort 2
1 of 4
Stage 2 Expansion Cohort 1
1 of 4
Experimental Treatment

108 Total Participants · 4 Treatment Groups

Primary Treatment: Furmonertinib · No Placebo Group · Phase 1

Stage 2 Expansion Cohort 3
Drug
Experimental Group · 1 Intervention: Furmonertinib · Intervention Types: Drug
Stage 1 Dose Escalation and Backfill
Drug
Experimental Group · 1 Intervention: Furmonertinib · Intervention Types: Drug
Stage 2 Expansion Cohort 2
Drug
Experimental Group · 1 Intervention: Furmonertinib · Intervention Types: Drug
Stage 2 Expansion Cohort 1
Drug
Experimental Group · 1 Intervention: Furmonertinib · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months after first dose
Closest Location: ArriVent Investigative Site · Orlando, FL
Photo of Orlando 1Photo of Orlando 2Photo of Orlando 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Respiratory Tract Neoplasms
0 CompletedClinical Trials

Who is running the clinical trial?

ArriVent BioPharma, Inc.Lead Sponsor
Morgan LamStudy DirectorArriVent BioPharma
2 Previous Clinical Trials
200 Total Patients Enrolled
Moran LamStudy DirectorArriVent BioPharma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a locally advanced or metastatic NSCLC.
You have documented evidence of an EGFR mutation in blood or tumor tissue.
Patients with a history of treated CNS metastases or new asymptomatic CNS metastases detected at screening are eligible.
You have been previously treated with EGFR-TKIs for NSCLC.
You have documented results from either local testing of blood or tumor tissue confirming the presence of EGFR exon 20 insertion mutations.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.