Study Objective

This Phase 3 clinical trial evaluates whether the combination of osimertinib and bevacizumab prolongs survival compared with monotherapy in patients with metastatic EGFR‑mutated non‑small cell lung cancer (NSCLC). Osimertinib blocks EGFR signaling, while bevacizumab inhibits angiogenesis to suppress tumor growth.

Population and Design

The study enrolls patients with EGFR‑mutant stage IIIB–IV metastatic NSCLC. Participants are randomized to receive either osimertinib monotherapy or osimertinib plus bevacizumab. The primary endpoint is progression‑free survival (PFS); secondary endpoints include overall survival (OS) and safety. The trial commenced in December 2020, with results anticipated around 2025.

Differentiation from Existing Therapies

Current standard therapy for EGFR‑mutated lung cancer is osimertinib monotherapy, with a median PFS of approximately 10–15 months. Bevacizumab has demonstrated efficacy through angiogenesis inhibition, but data on its combination with EGFR inhibitors are limited. Co‑administration of the two agents is expected to delay resistance emergence and modulate the tumor microenvironment, potentially enhancing therapeutic efficacy.

Market and Impact

Osimertinib is a flagship oncology product of AstraZeneca, while bevacizumab is a core anti‑cancer agent of Roche. If successful, both companies would secure additional revenue growth and deliver a novel first‑line option for the EGFR‑mutant patient population. Conversely, a negative outcome could reinforce the current monotherapy paradigm and dampen investment in combination studies.