Clinical trial NCT05498064: A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
Official title: A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase I1171N
Ensartinib
Keywords: Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase
Ensartinib
Real world study
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Betta Pharmaceuticals Co., Ltd.
First posted: 2022-08-11
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 36 months
Secondary outcomes:
measure: The objective response rate (ORR)
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 48 months
measure: 12 month/24 month/36 month/48 month-overall survival (OS) rate OS
timeFrame: 12 months，24 months，36 months，48 months
measure: Incidence of patients experiencing adverse events (AE)
timeFrame: 36 months
Other outcomes:
measure: Peak plasma concentration (Cmax) of Ensartinib.
timeFrame: Three hours after Ensartinib treatment
Locations:
city: Beijing
country: China
facility: Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
state: Beijing
Study officials:
References: