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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase I1171N; Ensartinib
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Anticipated): 490

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Defined as time from first dose of Ensartinib to disease progression or death due to any causes	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)	OS, defined as time from first dose of Ensartinib to death due to any cause	48 months
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
Incidence of patients experiencing adverse events (AE)	Adverse events are graded according to CTCAE 5.0	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of Ensartinib.	Evaluation of Ensartinib population Cmax pharmacokinetics.	Three hours after Ensartinib treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Betta Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Carcinoma, Non-Small-Cell Lung; Ensartinib; Anaplastic Lymphoma Kinase; Real world study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ensartinib
• Other Study ID Numbers: BD-EN-IV007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No