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

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.

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.