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
Qualifiers
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 design
Treatments tested in this trial
- Ensartinib
Treatment groups
No treatment groups listed
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Betta Pharmaceuticals Co., Ltd.
Collaborator
Source ClinicalTrials.gov