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Tyrosine Kinase Inhibitor

Furmonertinib for Non-Small Cell Lung Cancer

Phase 3
Recruiting
Research Sponsored by ArriVent BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented, locally advanced or metastatic non-squamous NSCLC not amenable to curative surgery or radiotherapy.
No prior systemic anticancer therapy regimens received for locally advanced or metastatic NSCLC including prior treatment with any EGFR-targeting agents (e.g., previous EGFR TKIs, monoclonal antibodies, or bispecific antibodies).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to ≤30 days after last dose
Awards & highlights

Study Summary

This trial will test a new drug in 375 patients with advanced lung cancer caused by a gene mutation. The drug will be compared to platinum-based chemo to see which is more effective and safe.

Who is the study for?
This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery or cured with radiotherapy. They must have a specific mutation in their cancer cells called EGFR exon 20 insertion and should not have had previous systemic anticancer treatments for advanced NSCLC, including any drugs targeting EGFR.Check my eligibility
What is being tested?
The study compares two doses of a new oral drug, furmonertinib (160 mg and 240 mg daily), against standard platinum-based chemotherapy in patients who haven't been treated before for their lung cancer. Participants will be randomly assigned to one of the three treatment groups.See study design
What are the potential side effects?
Potential side effects from furmonertinib may include diarrhea, rash, dry skin, nail changes, mouth sores, decreased appetite, vomiting and liver enzyme elevations. Platinum-based chemotherapy can cause nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced lung cancer cannot be cured with surgery or radiation.
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I haven't received any systemic anticancer treatments for my advanced NSCLC, including EGFR-targeting therapies.
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I haven't had cancer treatment for at least 12 months.
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I haven't received any treatments for advanced NSCLC, including EGFR-targeting therapies.
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My lung cancer cannot be cured with surgery or radiotherapy.
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My cancer has a specific EGFR mutation.
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I had treatment for cancer that hadn't spread, with no treatments in the last year.
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My tests show an EGFR exon 20 mutation in my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to ≤30 days after last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to ≤30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Secondary outcome measures
Central Nervous System
CNS ORR evaluated by BICR
Central Nervous System
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: furmonertinib 240 mgExperimental Treatment1 Intervention
furmonertinib tablet
Group II: furmonertinib 160 mgExperimental Treatment1 Intervention
furmonertinib tablet
Group III: platinum-based chemotherapyActive Control1 Intervention
carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Find a Location

Who is running the clinical trial?

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

Media Library

Furmonertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05607550 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: furmonertinib 240 mg, furmonertinib 160 mg, platinum-based chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Furmonertinib Highlights & Side Effects. Trial Name: NCT05607550 — Phase 3
Furmonertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607550 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this research project at this time?

"Unfortunately, this particular trial is not looking for any more participants. Although the most recent update on clinicaltrials.gov was from November 4th 2022, 6919 other studies are still recruiting patients."

Answered by AI

Has furmonertinib met the FDA's standards for safety and efficacy?

"Furmonertinib 160 mg has been shown to be safe in multiple clinical trials, and thus it receives a score of 3 on our Power scale."

Answered by AI

Who else is applying?

What state do they live in?
California
Indiana
New York
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Arrivent Investigative Site
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
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)
2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607550.
All > Lung Cancer Dallas > Toronto
~216 spots leftby Aug 2025
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