Trial results for the Neo-DIANA study (NCT04512430) investigating atezolizumab in combination with other agents for neoadjuvant treatment of EGFR-mutated non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-04-02. The Phase 2 study was terminated early after enrolling only 4 of the planned 26 participants.
Background
The Neo-DIANA trial aimed to evaluate a neoadjuvant treatment regimen for patients with locally advanced EGFR-mutated non-small cell lung carcinoma. Atezolizumab is an immunotherapy drug, and this study combined it with bevacizumab, carboplatin, and pemetrexed.
Trial design
The Neo-DIANA study (NCT04512430) was an open-label, non-randomized, Phase 2, multi-center clinical trial. It was designed to enroll 26 patients with locally advanced EGFR-mutated non-small cell lung cancer. The intervention arm included atezolizumab, bevacizumab, carboplatin, and pemetrexed. The trial was terminated early after enrolling only 4 participants, and no primary outcomes were listed in the posted results.
Key results
For the outcome of "Overall Response" in the "Experimental: Neo-Adjuvant Immunotherapy" group, the results reported counts of participants as 1, 2, and 1. These counts correspond to the total of 4 participants enrolled in the study before its early termination.
What this means
The early termination of the Neo-DIANA trial and its low enrollment of only 4 participants out of a planned 26 means that no conclusive data regarding the efficacy or safety of the atezolizumab combination regimen for EGFR-mutated non-small cell lung cancer can be drawn from these posted results. The trial was unable to gather sufficient data to evaluate its intended objectives.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04512430, titled "Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients," were posted on 2025-04-02 on clinicaltrials.gov.