Osimertinib Trial for Advanced NSCLC (EGFR/TP53) Reaches Primary Completion

The Phase 3 trial (NCT04695925) investigating osimertinib as monotherapy or in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC) with concurrent EGFR and TP53 mutations reached its primary completion on 2025-11-01. This milestone indicates that the study has finished collecting data for its primary outcome measures.

Background

Osimertinib (brand name Tagrisso) is an established therapy for non-small cell lung cancer (NSCLC) with EGFR mutations. This specific trial focuses on its use, either as monotherapy or in combination with chemotherapy, for patients with advanced non-squamous NSCLC who have both EGFR-sensitizing mutations and concurrent TP53 mutations, and are planned to receive first-line therapy.

Trial design

The trial, identified as NCT04695925, is a Phase 3 randomized study. It has an enrollment of 294 participants, focusing on individuals with advanced non-squamous non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations and concurrent TP53 mutations. Participants have a performance status of 0 to 1 and are planned to receive first-line therapy. The interventions being investigated include osimertinib monotherapy or its combination with pemetrexed and carboplatin.

What this means

The primary completion of this Phase 3 trial signifies that all planned data collection for the primary outcome measures has concluded. Researchers will now proceed with data analysis to evaluate the efficacy and safety of osimertinib, both as monotherapy and in combination with chemotherapy, in this specific population of advanced NSCLC patients with concurrent EGFR and TP53 mutations. The results from this study will be crucial for understanding potential new first-line treatment strategies for these patients.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04695925, titled "Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations," was posted on 2025-11-01 on clinicaltrials.gov.