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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498064
• Other study ID #: BD-EN-IV007
• Status: Recruiting
• Start date: May 13, 2022
• Est. completion date: December 1, 2028

Study information

• Verified date: August 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 1, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Ensartinib
Ensartinib 225 mg administered once daily orally

Locations

Country	Name	City	State
China	Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peak plasma concentration (Cmax) of Ensartinib.	Evaluation of Ensartinib population Cmax pharmacokinetics.	Three hours after Ensartinib treatment
Primary	Progression free survival (PFS)	Defined as time from first dose of Ensartinib to disease progression or death due to any causes	36 months
Secondary	The objective response rate (ORR)	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).	36 months
Secondary	Overall survival (OS)	OS, defined as time from first dose of Ensartinib to death due to any cause	48 months
Secondary	12 month/24 month/36 month/48 month-overall survival (OS) rate OS	Defined as the time from randomization to death from any cause. The OS rate was estimated based on the landmark analysis.	12 months,24 months,36 months,48 months
Secondary	Incidence of patients experiencing adverse events (AE)	Adverse events are graded according to CTCAE 5.0	36 months