Clinical Trial

***REFERRAL ONLY***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 with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

Brief Summary: This is a global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib at 2 dose levels (160 mg and 240 mg) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic nonsquamous NSCLC with EGFR exon 20 insertion mutations.

Key Eligibility Criteria:

• Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy
• Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation
• No prior systemic anticancer therapy regimens received for locally advanced or metastatic NSCLC including prior treatment with any EGFR -targeting agents
• Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months