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Trial Title:
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
NCT ID:
NCT05498064
Condition:
Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase I1171N
Ensartinib
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Ensartinib
Conditions: Keywords:
Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase
Ensartinib
Real world study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Ensartinib
Description:
Ensartinib 225 mg administered once daily orally
Summary:
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.
Detailed description:
Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will
continue until disease progression, meeting one of treatment discontinuation criteria
(eg, patient decision, adverse event, pregnancy). At the time of disease progression,
participants will enter a survival follow-up until death, withdrawal of consent or study
closure, whichever occurs earlier. Collection of venous blood sample from participants
included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood
specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of
Ensartinib population pharmacokinetics with blood sampling after 8 weeks.
Criteria for eligibility:
Study pop:
Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the
International Association for the Study of Lung Cancer staging manual in Thoracic
Oncology, 8th edition.
2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
3. Patients must have demonstrated progression during or after ALK-TKI treatment;
4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall
survival>3 months;
5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic
lesions, intrapulmonary lesions, adrenal lesions, etc.
6. Initially general blood tests including complete blood count, biochemistry,
electrolytes, and urine biochemistry were performed as a routine screening in order
to identify any abnormalities.
7. Male and female patients must agree to abstain or to use two highly effective forms
of contraception during the treatment period and for 90 days after the last dose of
study medication.
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Xu, Dr.
Phone:
8601069155154
Email:
maraxu@163.com
Investigator:
Last name:
Mengzhao Wang
Email:
Principal Investigator
Start date:
May 13, 2022
Completion date:
December 1, 2028
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498064
