A Real World Study of Ensartinib in Advanced ALK-positive NSCLC

Recruiting now

Conditions studied: Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib

In brief

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.

Key facts

Study ID

NCT05498064

Run by

Peking Union Medical College Hospital

People needed

490

Starts

2022-05-13

Expected to finish

2028-12-01

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.
• 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.
• 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.

Where it is running

• Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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