eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Phase 3 Active not recruiting 290 enrolled Xcovery Holdings, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

Timeline

Start: 2016-06
Primary completion: 2025-12-30
Completion: 2025-12-31

Outcome

Met primary endpoint

paper median PFS was significantly longer with ensartinib than with crizotinib (25.8 [range, 0.03-44.0 months] vs 12.7 months [range, PMID 34473194 ↗

paper hazard ratio, 0.51 [95% CI, 0.35-0.72]; log-rank P < .001 PMID 34473194 ↗

release “盐酸恩沙替尼国际多中心Ⅲ期临床研究（ eXalt3 ）重磅期中分析结果。结果显示，接受恩沙替尼治疗的 ALK 阳性非小细胞肺癌（ NSCLC ）患者，其中位无进展生存期（ mPFS ）显著长于接受克唑替尼治疗的患者。” bettapharma.com ↗

Publications

Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1617-1625. doi: 10.1001/jamaoncol.2021.3523.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Crizotinib	Small molecule	250 mg	—
Subject	Ensartinib	Small molecule	225 mg	Oral