Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2028-02-15
• Target enrollment: 0
• Participant gender: All

Summary

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib 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 NSCLC with 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArriVent BioPharma, Inc.
• Collaborator: Allist Pharmaceuticals, Inc.
• Treatments: Aflutinib

Criteria

Key Inclusion Criteria:

• Histologically or cytologically documented, locally advanced or metastatic non-squamous NSCLC not amenable to curative surgery or radiotherapy.

• Documented validated results confirming the presence of an EGFR exon 20 insertion mutation in tumor tissue or blood from local or central testing.

• 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).

• Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemoradiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.

• Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.