MedPath

Ensartinib

Generic Name
Ensartinib
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C26H27Cl2FN6O3
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
-

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
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
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
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
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
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
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
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
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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