A PHASE3 clinical trial investigating Pembrolizumab (Keytruda) in combination with other agents for unresectable, locally advanced or metastatic non-small cell lung cancer with HER2 mutations reached its primary completion on 2026-06-09. This milestone signifies the completion of data collection for the study's primary endpoints, moving the trial closer to potential results.
Background
The trial focuses on Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) specifically in patients with HER2 Exon 19 or 20 mutations. This patient population represents a specific subset of NSCLC where targeted therapies are being explored. Pembrolizumab is an immunotherapy commonly used in various cancers, while trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate targeting HER2.
Trial design
The study, identified as NCT05048797 and known as DESTINY-Lung04, is a PHASE3 trial with an enrollment of 454 participants. It is designed to investigate the efficacy and safety of trastuzumab deruxtecan versus Standard of Care (SoC) as first-line treatment for NSCLC with HER2 Exon 19 or 20 mutations. The interventions include trastuzumab deruxtecan, cisplatin, carboplatin, pembrolizumab, and pemetrexed. The trial is currently in an ACTIVE_NOT_RECRUITING status.
What this means
The primary completion of this PHASE3 trial is a significant step in the evaluation of new treatment options for patients with HER2-mutated non-small cell lung cancer. It indicates that all data required for the primary endpoints have been collected, and the study is now progressing towards data analysis and eventual reporting of results. This trial aims to provide crucial insights into the potential role of trastuzumab deruxtecan and standard chemotherapy regimens, including those with pembrolizumab, in this challenging disease setting.
Source
This primary completion status was reported on ClinicalTrials.gov on 2026-06-09. Further details regarding the study, NCT05048797, can be found on clinicaltrials.gov.