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.

Furmonertinib

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 tyrosine kinase inhibitors (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.

Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently

Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable, and has symptomatically improved.

Severe acute or chronic infections