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)

Conditions

• Advanced Non-Small Cell Lung Cancer
• EGFR Exon 20 Mutations
• Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• furmonertinib 240 mg oral, daily — DRUG
  furmonertinib tablet
• furmonertinib 160 mg oral, daily — DRUG
  furmonertinib tablet
• platinum-based chemotherapy — DRUG
  (carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Study Details

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.

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2025

Primary completion

Aug 15, 2025

Completion

Feb 15, 2028

Study Design

Enrollment

398 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: furmonertinib 240 mg
• Experimental: furmonertinib 160 mg
• Active Comparator: platinum-based chemotherapy
  carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

Primary Outcome Measure

Progression Free Survival (PFS) determined by blinded independent central review (BICR) [ Time Frame: Up to 32 months after first dose ]

Locations (69)

Find similar trials in Daphne, AL

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