Ensartinib

Generic Name: Ensartinib

Brand Names: -

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。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

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 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

A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer

Phase 2

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Ensartinib

First Posted Date: 2022-05-18

Last Posted Date: 2022-08-18

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 10

Registration Number: NCT05380024

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China
🇨🇳
NAN Wu, Beijing, Beijing, China

Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Placebo
Drug: Ensartinib

First Posted Date: 2022-04-22

Last Posted Date: 2024-08-23

Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Target Recruit Count: 202

Registration Number: NCT05341583

Locations: 🇨🇳
TianJin Medical University Cancer Institute & Hospital, Tianjin, China

Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Ensartinib

First Posted Date: 2022-02-15

Last Posted Date: 2023-10-10

Lead Sponsor: Hebei Medical University Fourth Hospital

Target Recruit Count: 80

Registration Number: NCT05241028

Locations: 🇨🇳
Jun Feng Liu, Shijiazhuang, Hebei, China

Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance

Phase 2

Recruiting

Conditions: Second Generation ALK-TKI is Resistant
The Diagnosis Was ALK Positive NSCLC
Efficacy of Ensatinib in This Subset of Patients

Interventions: Drug: Ensartinib

First Posted Date: 2022-01-05

Last Posted Date: 2022-01-05

Lead Sponsor: Li Zhang, MD

Target Recruit Count: 40

Registration Number: NCT05178511

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

Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Stage IIIC Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8

Interventions: Biological: Bevacizumab
Drug: Carboplatin
Drug: Ensartinib
Drug: Pemetrexed

First Posted Date: 2021-04-08

Last Posted Date: 2024-10-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 12

Registration Number: NCT04837716

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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