Anaplastic Lymphoma Kinase I1171N, Carcinoma, Non-Small-Cell Lung, Ensartinib
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase, Ensartinib, Real world study
Brief 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.
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
DRUGEnsartinib
Ensartinib 225 mg administered once daily orally
Sponsors
Betta Pharmaceuticals Co., Ltd.
Peking Union Medical College Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 36 months | Defined as time from first dose of Ensartinib to disease progression or death due to any causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The objective response rate (ORR) | 36 months | ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR). |
| Overall survival (OS) | 48 months | OS, defined as time from first dose of Ensartinib to death due to any cause |
| 12 month/24 month/36 month/48 month-overall survival (OS) rate OS | 12 months，24 months，36 months，48 months | Defined as the time from randomization to death from any cause. The OS rate was estimated based on the landmark analysis. |
| Incidence of patients experiencing adverse events (AE) | 36 months | Adverse events are graded according to CTCAE 5.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of Ensartinib. | Three hours after Ensartinib treatment | Evaluation of Ensartinib population Cmax pharmacokinetics. |
Countries
China
Outcome results
None listed