A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
Patients must have demonstrated progression during or after ALK-TKI treatment;
Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival>3 months;
Disqualifiers
None
Trial population
Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Ensartinib
DrugEnsartinib 225 mg administered once daily orally
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression free survival (PFS)
Defined as time from first dose of Ensartinib to disease progression or death due to any causes
Time frame
36 monthsSecondary outcomes
1
The objective response rate (ORR)
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Time frame
36 months2
Overall survival (OS)
OS, defined as time from first dose of Ensartinib to death due to any cause
Time frame
48 months3
12 month/24 month/36 month/48 month-overall survival (OS) rate OS
Defined as the time from randomization to death from any cause. The OS rate was estimated based on the landmark analysis.
Time frame
12 months，24 months，36 months，48 months4
Incidence of patients experiencing adverse events (AE)
Adverse events are graded according to CTCAE 5.0
Time frame
36 monthsOther outcomes
1
Peak plasma concentration (Cmax) of Ensartinib.
Evaluation of Ensartinib population Cmax pharmacokinetics.
Time frame
Three hours after Ensartinib treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Betta Pharmaceuticals Co., Ltd.
Collaborator
Source ClinicalTrials.gov