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)

Condition(s) studied

Investigational drug(s) / intervention(s)

furmonertinib 240 mg oral, daily: furmonertinib tablet

furmonertinib 160 mg oral, daily: furmonertinib tablet

platinum-based chemotherapy: (carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Study 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.

Eligibility

Primary outcome measure(s)

• Progression Free Survival (PFS) determined by blinded independent central review (BICR) — Up to 32 months after first dose

Trial sites (208)

+ 168 more sites — see the full list on the official registry below.