A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ensartinib.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Overview
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.
Detailed 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.
Interventions
- Drug Ensartinib
Ensartinib 225 mg administered once daily orally
Primary outcome measures
- Progression free survival (PFS) [Time frame: 36 months]
Secondary outcome measures (4)
- The objective response rate (ORR) [Time frame: 36 months]
- Overall survival (OS) [Time frame: 48 months]
- 12 month/24 month/36 month/48 month-overall survival (OS) rate OS [Time frame: 12 months，24 months，36 months，48 months]
- Incidence of patients experiencing adverse events (AE) [Time frame: 36 months]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospita — Beijing
Identifiers
NCT: NCT05498064 · BD-EN-IV007