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

NCT05498064 | Recruiting

• 1 other identifier: BD-EN-IV007
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase I1171N; Ensartinib

Keywords

Carcinoma, Non-Small-Cell Lung; Anaplastic Lymphoma Kinase; Ensartinib; Real world study

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Defined as time from first dose of Ensartinib to disease progression or death due to any causes

  36 months

Secondary Outcomes (4)

• The objective response rate (ORR)

  36 months

• Overall survival (OS)

  48 months

• 12 month/24 month/36 month/48 month-overall survival (OS) rate OS

  12 months，24 months，36 months，48 months

• Incidence of patients experiencing adverse events (AE)

  36 months

Other Outcomes (1)

• Peak plasma concentration (Cmax) of Ensartinib.

  Three hours after Ensartinib treatment

Interventions

Ensartinib DRUG

Ensartinib 225 mg administered once daily orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director of Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: August 11, 2022
• Study Start: May 13, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)