Ensartinib

Generic Name: Ensartinib

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₇Cl_₂FN_₆O_₃

CAS Number: 1370651-20-9

Unique Ingredient Identifier: SMA5ZS5B22

Background: Ensartinib is under investigation in clinical trial NCT03420508 (Treating Patients With Melanoma and ALK Alterations With Ensartinib).

Indication: 用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的二线治疗。

Clinical Trials

Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations

Phase 3

Not yet recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Icotinib
Drug: Rezivertinib
Drug: Ensartinib
Drug: Benmelstobart

First Posted Date: 2025-05-02

Last Posted Date: 2025-05-06

Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 270

Registration Number: NCT06955325

Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study

Phase 4

Not yet recruiting

Conditions: ALK-positive Advanced NSCLC
ALK-positive Non-small Cell Lung Cancer (NSCLC)
MPR
Neoadjuvant Therapy

Interventions: Drug: Ensartinib

First Posted Date: 2025-01-21

Last Posted Date: 2025-01-21

Lead Sponsor: Fujian Medical University Union Hospital

Target Recruit Count: 30

Registration Number: NCT06785584

Locations: 🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

Phase 2

Not yet recruiting

Conditions: NSCLC, Stage I, II, IIIA, IIIB

Interventions: Drug: Ensartinib

First Posted Date: 2025-01-17

Last Posted Date: 2025-01-17

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 70

Registration Number: NCT06780839

Locations: 🇨🇳
Beijing cancer hospital, Beijing, Beijing, China

Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer

Phase 2

Not yet recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Ensartinib

First Posted Date: 2025-01-16

Last Posted Date: 2025-01-17

Lead Sponsor: West China Hospital

Target Recruit Count: 33

Registration Number: NCT06779539

Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

Phase 2

Not yet recruiting

Conditions: Solid Tumors

Interventions: Drug: Ensartinib

First Posted Date: 2025-01-07

Last Posted Date: 2025-01-07

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Target Recruit Count: 20

Registration Number: NCT06762327

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Phase 2

Recruiting

Conditions: Mutation
Lung Cancer Stage III

Interventions: Drug: Glecirasib
Drug: Dabrafenib+Trametinib
Drug: Larotrectinib
Drug: Crizotinib
Drug: Sunvozertinib
Drug: Pralsetinib
Drug: Savolitinib
Drug: Pyrotinib
Drug: Ensartinib

First Posted Date: 2024-08-21

Last Posted Date: 2024-12-10

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 120

Registration Number: NCT06563999

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

Phase 1

Not yet recruiting

Conditions: Healthy

Interventions: Drug: Ensartinib
Drug: Itraconazole
Drug: Rifampicin

First Posted Date: 2024-07-09

Last Posted Date: 2024-07-09

Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Target Recruit Count: 36

Registration Number: NCT06492525

Locations: 🇨🇳
The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

Phase 1

Completed

Conditions: Bioequivalency

Interventions: Drug: Ensartinib Hydrochloride

First Posted Date: 2022-12-27

Last Posted Date: 2024-02-20

Lead Sponsor: Xcovery Holdings, Inc.

Target Recruit Count: 32

Registration Number: NCT05665283

Locations: 🇺🇸
ICON - Early Development Services, Lenexa, Kansas, United States

A Real World Study of Ensartinib in Advanced ALK-positive NSCLC

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase I1171N
Ensartinib

First Posted Date: 2022-08-11

Last Posted Date: 2022-08-11

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 490

Registration Number: NCT05498064

Locations: 🇨🇳
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Beijing, Beijing, China

Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Ensartinib
Drug: Bevacizumab

First Posted Date: 2022-08-08

Last Posted Date: 2024-05-02

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 58

Registration Number: NCT05491811

Locations: 🇨🇳
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Drug Development Updates

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