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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ensartinib for patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The main goal is to see how well this drug works and how safe it is for patients whose cancer has progressed after previous treatments. The study looks to understand how the body processes Ensartinib and why some patients may not respond to it as expected.

To participate in the trial, patients need to have a confirmed diagnosis of advanced NSCLC and show that their cancer has continued to grow despite other treatments. Eligible participants should generally be in good health, with a performance status that indicates they can carry out daily activities. The trial is open to both men and women aged 65 and older, and participants will be monitored closely throughout the study. It's important to note that individuals must agree to use effective birth control during the trial and for a period afterward.

Gender

ALL

Eligibility 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:
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