Trials / Active Not Recruiting
Active Not RecruitingNCT05607550
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)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 398 (actual)
- Sponsor
- ArriVent BioPharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | furmonertinib 240 mg oral, daily | furmonertinib tablet |
| DRUG | furmonertinib 160 mg oral, daily | furmonertinib tablet |
| DRUG | platinum-based chemotherapy | (carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV) |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2025-08-15
- Completion
- 2028-02-15
- First posted
- 2022-11-07
- Last updated
- 2025-06-22
Locations
208 sites across 19 countries: United States, Australia, Brazil, Canada, China, France, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05607550. Inclusion in this directory is not an endorsement.