Ensacove (ensartinib)

P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

P4, N=178, Not yet recruiting, Beijing chest hospital capital medical university; Beijing Chest Hospital Capital Medical University

P4, N=20, Not yet recruiting, The Second Affiliated Hospital of Air Force Medical University; The Second Affiliated Hospital of Air Force Medical University

P2, N=45, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

P1/2, N=20, Not yet recruiting, Tang-Du Hospital

P2, N=1376, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> Jan 2027

This case emphasizes that nodules with diffuse, popcorn-like calcification do not rule out the possibility of lung cancer. A comprehensive evaluation integrating multidimensional imaging features is necessary. For nodules with conflicting imaging characteristics, minimally invasive surgical resection remains valuable for diagnosis. This approach broadens our diagnostic perspective on calcified nodules, enhances clinicians' understanding of lung adenocarcinoma, and reduces the rate of misdiagnosis.

P2, N=45, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

This retrospective study included patients who developed CNS progression (time 0, [T0]) on alectinib, lorlatinib, brigatinib, or ensartinib. The median intracranial progression-free survival from T0 was not significantly different between the TKI-altered versus unaltered groups (p = 0.21). For patients with ALK-rearranged NSCLC with leptomeningeal progression or concurrent systemic progression, TKI change or dose increase was a feasible salvage strategy for CNS progression during treatment with CNS-penetrable TKI.

The patient received first-line chemotherapy with pemetrexed (820 mg on day 1) plus cisplatin (40 mg on days 1-3) every 21 days and achieved a remarkable progression-free survival (PFS) of 48 months...She was subsequently treated with ensartinib (225 mg once daily), yielding a favorable response...Unless there are studies with large cohorts clarifying the case, an individualized regimen-potentially starting with chemotherapy and transitioning to targeted agents-may be justified. Further clinical experience and collaborative research are essential to develop evidence-based guidelines for this exceptionally rare subset.

EST and Encorafenib (ECB as the internal standard) were differentiated using an isocratic mobile phase system on a reversed stationary phase (Eclipse Plus C18) column. In silico data proposed that minor structural modifications to the dichlorophenyl moiety or the piperazine ring during drug design may enhance the safety profile and metabolic stability relative to the properties of EST. Evaluating the EST metabolic stability and in silico ADME characteristics is essential for advancing innovative therapeutic research focused on improving metabolic stability.

Phase III trial confirmed superior PFS with ensartinib compared to crizotinib. This review received no specific funding. The protocol was not registered.