Phase 2 Study Testing Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Adults With Untreated Brain Metastases From Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a combination treatment for patients with metastatic non-small cell lung cancer NSCLC who have brain metastases but no known actionable mutations. This phase II, single-arm, multicenter trial aims to assess the effectiveness of Datopotamab-deruxtecan combined with Carboplatin and Pembrolizumab. The study focuses on patients who have not received prior systemic therapy for advanced NSCLC and measures brain tumor responses using established criteria over an average of two years. Participants will receive an induction phase of treatment every three weeks for four cycles, including Datopotamab-deruxtecan 6 mgkg, Carboplatin, and Pembrolizumab 200 mg. Following this, they will continue maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or unacceptable side effects occur. If brain tumors progress without systemic disease worsening, patients may undergo stereotactic radiosurgery and continue systemic therapy depending on the investigators decision. Throughout the study, patients will have medical evaluations and laboratory tests every three weeks. Imaging scans of the abdomen, pelvis, chest, and brain will be done at baseline, every six weeks for the first 24 weeks, then every nine weeks afterward. Patient-reported outcomes will be collected using questionnaires during treatment. The main outcome measured is the confirmed response rate of brain metastases based on specific imaging criteria, with safety and quality of life also monitored.

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)