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

Last updated: August 10, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05498064
BD-EN-IV007
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to theInternational Association for the Study of Lung Cancer staging manual in ThoracicOncology, 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, overallsurvival>3 months;
  5. Patients need radiotherapy or can receive radiotherapy, such as bone metastaticlesions, 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 toidentify any abnormalities.
  7. Male and female patients must agree to abstain or to use two highly effective forms ofcontraception during the treatment period and for 90 days after the last dose of studymedication.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 490
Study Start date:
May 13, 2022
Estimated Completion Date:
December 01, 2028

Study Description

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.

Connect with a study center

  • Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.