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

  • End date
    Dec 1, 2028
  • participants needed
  • sponsor
    Peking Union Medical College Hospital
Updated on 4 October 2022
lung carcinoma


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.


Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.

Condition Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib
Treatment Ensartinib
Clinical Study IdentifierNCT05498064
SponsorPeking Union Medical College Hospital
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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