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Tyrosine Kinase Inhibitor

Furmonertinib for Non-Small Cell Lung Cancer

Phase 1
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
Documented validated results from local testing of blood or tumor tissue confirming the presence of an EGFR Exon 20 insertion mutation, HER2 Exon 20 insertion mutation, or EGFR activating mutation.
Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months after first dose
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective. Patients with lung cancer caused by mutations in EGFR or HER2 may be eligible to participate.

Who is the study for?
This trial is for adults with advanced or metastatic NSCLC who have specific EGFR or HER2 mutations. They must have progressed after standard therapy, including osimertinib if applicable, and may have treated brain metastases. Those ineligible include patients with recent cancer therapies, active malignancies within the last 5 years (except certain skin cancers), or those living outside the US.Check my eligibility
What is being tested?
The study tests Furmonertinib's safety and effectiveness in two stages: dose escalation to find a safe dosage and dose expansion to further assess its impact on lung cancer with certain genetic changes. It's an early-phase trial for patients whose cancer has worsened despite previous treatments.See study design
What are the potential side effects?
While not explicitly listed here, side effects of Furmonertinib could include typical reactions to cancer drugs such as nausea, fatigue, liver issues, rash or other skin problems. The exact side effects will be monitored closely given this is an early-stage trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tests show a specific mutation in my cancer (EGFR or HER2).
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My tests show a specific mutation in my cancer.
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My tests show an uncommon EGFR mutation in my cancer.
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My cancer has worsened after my last cancer treatment.
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My lung cancer cannot be cured with surgery or radiation.
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I have taken osimertinib for my EGFR-mutant cancer, as it's approved in my region.
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I have taken osimertinib for my EGFR-mutant cancer, as it's approved in my region.
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My lung cancer cannot be cured with surgery or radiation.
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My condition worsened after treatment, or treatments didn't work or caused severe side effects.
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My cancer has worsened after my last cancer treatment.
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My cancer got worse or I couldn't tolerate platinum-based chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months after first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months after first 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
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Stage 2: Overall Response Rate (ORR)
Secondary outcome measures
Brain Diseases, Metabolic
Midazolam
Stage 1: Central Nervous System DOR
+18 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Stage 2 Expansion Cohort 4Experimental Treatment1 Intervention
Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations
Group II: Stage 2 Expansion Cohort 3Experimental Treatment1 Intervention
Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4
Group III: Stage 2 Expansion Cohort 2Experimental Treatment1 Intervention
Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations
Group IV: Stage 2 Expansion Cohort 1Experimental Treatment1 Intervention
Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations
Group V: Stage 1 Dose Escalation and BackfillExperimental Treatment1 Intervention
Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations

Find a Location

Who is running the clinical trial?

ArriVent BioPharma, Inc.Lead Sponsor
1 Previous Clinical Trials
375 Total Patients Enrolled
Moran LamStudy DirectorArriVent BioPharma
Morgan LamStudy DirectorArriVent BioPharma
3 Previous Clinical Trials
575 Total Patients Enrolled

Media Library

Furmonertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05364073 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Stage 1 Dose Escalation and Backfill, Stage 2 Expansion Cohort 1, Stage 2 Expansion Cohort 2, Stage 2 Expansion Cohort 3, Stage 2 Expansion Cohort 4
Non-Small Cell Lung Cancer Clinical Trial 2023: Furmonertinib Highlights & Side Effects. Trial Name: NCT05364073 — Phase 1
Furmonertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364073 — Phase 1

Frequently Asked Questions

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

Is access to this research open to individuals seeking medical assistance?

"The trial's records on clinicaltrials.gov confirm that the study is presently seeking participants, with its first posting occuring June 30th 2022 and most recent revisions occurring November 10th 2022."

Answered by AI

What is the total enrollment rate for this research endeavor?

"Affirmative. Clinicaltrials.gov hosts data that indicates this clinical trial is recruiting patients; it was first posted on June 30th 2022 and was most recently updated on November 10th of the same year. The study requires 170 individuals from 11 different sites to be enrolled."

Answered by AI

How many venues are hosting this research endeavor?

"The clinical trial is currently open to enrolment at 11 sites, which include Detroit, Sacramento and Westwood. To reduce the burden of travelling for participants, it is advised that they select a site near them."

Answered by AI

What risks have been associated with Furmonertinib use?

"Our team at Power gave Furmonertinib a score of 1 on the safety scale, as Phase 1 trials typically have limited data supporting its efficacy and security."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
ArriVent Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
2022. "Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05364073.
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