Trial results for osimertinib (Tagrisso) in patients with EGFR-positive non-small cell lung cancer (NSCLC) and brain metastases were posted on ClinicalTrials.gov on 2026-03-17. The study, NCT02971501, showed that osimertinib monotherapy achieved a median progression-free survival (PFS) of 63.7 months, significantly outperforming the 15.2 months observed with osimertinib combined with bevacizumab.
Background
This study investigated osimertinib, a targeted therapy for EGFR-positive non-small cell lung cancer, with or without bevacizumab. Osimertinib is known to block enzymes necessary for tumor cell growth, while bevacizumab aims to inhibit tumor growth by blocking the development of new blood vessels.
Trial design
The Phase 2 trial, NCT02971501, titled "Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases," enrolled 5 participants. The study focused on patients with EGFR positive non-small cell lung cancer that had spread to the brain (brain metastases), specifically those with Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, and Stage IV Lung Cancer AJCC v8. Participants were treated with either osimertinib in combination with bevacizumab (Arm I) or osimertinib monotherapy (Arm II).
Key results
The trial reported significant differences in Progression Free Survival (PFS) between the two treatment arms:
- For the "Progression Free Survival (PFS)" outcome in Arm I (Osimertinib, Bevacizumab), the median PFS was 15.2 months.
- For the "Progression Free Survival (PFS)" outcome in Arm II (Osimertinib), the median PFS was 63.7 months.
What this means
The results from this Phase 2 trial suggest that osimertinib monotherapy may offer a substantially longer progression-free survival for patients with EGFR-positive non-small cell lung cancer and brain metastases compared to its combination with bevacizumab. The median PFS of 63.7 months for osimertinib alone, versus 15.2 months for the combination, indicates that adding bevacizumab did not improve outcomes in this study and may have been associated with a shorter PFS. These findings are important for guiding treatment decisions in this challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02971501, titled "Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases," were posted on 2026-03-17 on clinicaltrials.gov.