Clinical trials: Ensartinib
ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC)
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
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths).
- Conditions
- ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy
- Trial name
- NCT06785584
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fujian Medical University Union Hospital
Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib
- Trial name
- NCT05498064
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 490 people
- Sponsor
- Peking Union Medical College Hospital
ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
ALK TKIs, particularly second- and third-generation ALK TKIs, have significantly improved progression-free survival (PFS) in patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
- Trial name
- NCT07671560
- Testing
- Combined group of ensatinib and arotinib
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qiming Wang
NSCLC Stage III, Ensartinib
Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC
The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC).
- Conditions
- NSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK
- Trial name
- NCT07235306
- Testing
- Ensartinib 225mg
- Volunteers
- 45 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Bioequivalency
A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions
This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules…
- Trial name
- NCT05665283
- Testing
- Ensartinib Hydrochloride
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Xcovery Holdings, Inc.
NSCLC (Non-small Cell Lung Cancer)
Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)
The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC).
- Trial name
- TD-ENSEMBLE (NCT07354061)
- Testing
- Ensartinib + Chemotherapy
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Tang-Du Hospital
Non-small Cell Lung Cancer, Carcinoma
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in…
- Conditions
- Non-small Cell Lung Cancer, Carcinoma, NSCLC
- Trial name
- NCT02898116
- Testing
- Ensartinib, Durvalumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Ludwig Institute for Cancer Research
Advanced Solid Tumors, Non-small Cell Lung Cancer
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans…
- Trial name
- NCT01625234
- Testing
- Phase I: X-396 (ensartinib), Phase II: X-396 (ensartinib)
- Where
- 14 sites in United States
- Volunteers
- 131 people
- Sponsor
- Xcovery Holdings, Inc.
ALK-POSITIVE NSCLC
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] Ensartinib in healthy Chinese male subjects.
- Trial name
- NCT03804541
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
NSCLC, Stage I, II, IIIA, IIIB
Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD
To explore the efficacy and safety of ensartinib on adjuvant therapy guided by MRD in IA3-IIIB (T3N2) stage ALK-positive non-small cell lung cancer patients.
- Trial name
- NCT06780839
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Peking University Cancer Hospital & Institute
ALK Positive, Ensartinib
A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0…
- Conditions
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant Therapy
- Trial name
- NCT06736561
- Volunteers
- 100 people
- Sponsor
- Harbin Medical University
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer
This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage…
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT04837716
- Testing
- Bevacizumab, Carboplatin, Ensartinib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- M.D. Anderson Cancer Center
NSCLC, ALK
The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors
This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors.
- Conditions
- NSCLC, ALK, Stage I, Adjuvant Treatment
- Trial name
- NCT06772610
- Testing
- Ensartinib group
- Volunteers
- 40 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Solid Tumor, Non-Small Cell Lung Cancer Metastatic
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer
- Trial name
- NCT02959619
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Healthy
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
- Trial name
- NCT06492525
- Testing
- Ensartinib, Rifampicin, Itraconazole
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell…
- Trial name
- NCT05341583
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion.
- Trial name
- NCT05241028
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Hebei Medical University Fourth Hospital
Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396).
- Trial name
- NCT04146571
- Testing
- Ensartinib
- Where
- 4 sites in United States
- Sponsor
- Xcovery Holdings, Inc.
Non-Small Cell Lung Cancer
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC)…
- Trial name
- EAGLE (NCT05491811)
- Testing
- Ensartinib, Bevacizumab
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Sun Yat-sen University
Lung Cancer
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
- Trial name
- NCT03536481
- Testing
- ensartinib capsules (test product), ensartinib capsules (reference product)
- Where
- China
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.