Evaluating Ensartinib for Advanced ALK-positive Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy and safety of Ensartinib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). Participants will take Ensartinib orally once daily, and treatment will continue until disease progression or other specified discontinuation criteria are met. Blood samples will be collected at three time points to analyze ctDNA and evaluate the pharmacokinetics of Ensartinib. The study will also monitor participants' survival following disease progression.

Why it matters

Who can join: the full rules

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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Where it's running

• Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.