[Translation] A phase III, open-label, sponsor-blinded, randomized study evaluating Dato-DXd with or without osimertinib versus platinum-based chemotherapy in participants with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who have progressed on prior osimertinib (TROPION-Lung15)
本研究旨在评估 Dato-DXd 联合或不联合奥希替尼对比含铂化疗在既往奥希替尼治疗出现疾病进展的EGFRm 局部晚期或转移性 NSCLC 参与者中的疗效。拟定双主要研究终点旨在证明 Dato-DXd 联合和不联合奥希替尼在盲态独立中心审查(BICR)评估的 PFS 方面相较于化疗的优效性。关键次要有效性终点是OS和CNS PFS。还将评估 Dato-DXd 联合或不联合奥希替尼相较于化疗的安全性和耐受性特征。
[Translation] This study is designed to evaluate Dato-DXd with or without osimertinib versus platinum-based chemotherapy in participants with EGFRm locally advanced or metastatic NSCLC who have progressed on prior osimertinib therapy. The proposed dual primary endpoints are to demonstrate the superiority of Dato-DXd with or without osimertinib versus chemotherapy with respect to PFS assessed by blinded independent central review (BICR). Key secondary efficacy endpoints are OS and CNS PFS. The safety and tolerability profile of Dato-DXd with or without osimertinib versus chemotherapy will also be evaluated.