- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241028
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
October 6, 2023 updated by: LiuJunFeng, Hebei Medical University Fourth Hospital
Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study
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.
Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junfeng Liu, PhD
- Phone Number: 13931152296
- Email: liujf@hbmu.edu
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050011
- Recruiting
- Jun Feng Liu
-
Contact:
- Jun Feng Liu, PhD
- Phone Number: 13931152296
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS).
- Males or females aged ≥18 years, ≤75 years.
- ECOG performance status 0-2.
- Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments).
- Clinical examinations before treatment report no signs of disease recurrance.
- With enough tumor histology specimens (non-cytology) for molecular marker analysis.
- hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L.
- Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN;
- Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min;
- Signed inform consent form by patient or his/her legal representative.
- Comply with study protocol and procedure, and be able to take oral medication.
- Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment.
- Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy.
Exclusion Criteria:
- Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past.
- Having local radiotherapy of NSCLC.
- Known allergy to Ensatinib or any of the ingredients in this product.
- Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis.
- Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases.
- Women who are pregnant or breastfeeding.
- Having history of neurological or psychiatric disorders, including epilepsy or dementia.
- Other conditions investigators evaluate that patient is not eligible to this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ensartinib
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
|
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year disease free survival rate (DFSR)
Time Frame: 3 years
|
Defined as the percentage of patients alive and disease free at 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year overall survival rate
Time Frame: 5 years
|
Defined as the percentage of patients alive at 5 years
|
5 years
|
disease free survival (DFS)
Time Frame: Up to 5 years
|
Defined as the time from the date of starting treatment until the date of disease recurrence or death (by any cause in the absence of recurrence)
|
Up to 5 years
|
overall survival (OS)
Time Frame: Up to 5 years
|
Defined as the time from starting treatment to death.
|
Up to 5 years
|
Adverse Events
Time Frame: Up to 3 years
|
The safety and tolerability profile of Ensartinib
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2029
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
February 6, 2022
First Posted (Actual)
February 15, 2022
Study Record Updates
Last Update Posted (Actual)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Ensartinib
Other Study ID Numbers
- BD-EN-IV006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Ensartinib
-
Xcovery Holding Company, LLCCompletedAdvanced Solid Tumors | Non-small Cell Lung CancerUnited States
-
Xcovery Holding Company, LLCActive, not recruitingNon-small Cell Lung CancerSpain, United States, China, Korea, Republic of, Canada, Hong Kong, United Kingdom, Turkey, Belgium, France, Poland, Israel, Australia, Argentina, Brazil, Czechia, Germany, Italy, Netherlands, Peru, Russian Federation
-
Xcovery Holdings, Inc.CompletedBioequivalencyUnited States
-
Fudan UniversityBetta Pharmaceuticals Co., Ltd.UnknownNonsmall Cell Lung Cancer | Brain Metastases
-
Betta Pharmaceuticals Co., Ltd.Completed
-
Betta Pharmaceuticals Co., Ltd.Fudan UniversityUnknownBrain Metastases | Lung Cancer, Nonsmall CellChina
-
Betta Pharmaceuticals Co., Ltd.CompletedNon-Small Cell Lung CancerChina
-
Janssen Research & Development, LLCCompletedDepressive Disorder | AnxietyUkraine, United Kingdom, Spain, United States, Russian Federation, Moldova, Republic of
-
Peking University Cancer Hospital & InstituteRecruitingNon Small Cell Lung CancerChina
-
Betta Pharmaceuticals Co., Ltd.CompletedSolid Tumor | Non-Small Cell Lung Cancer MetastaticChina