Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer (EFLRWR)

Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

1. Efficacy and safety;
2. The relationship between molecular mechanism and curative effect;
3. Ensatinib resistance mechanism;

Study Overview

• Status: Recruiting
• Conditions: NSCLC Stage IV; NSCLC Stage IIIB; ALK Positive
• Intervention / Treatment: Drug: Ensatinib

Detailed Description

Enrolled patients:

1. stage IIIB or stage IV NSCLC
2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Jun Zhao, PhD; Phone Number: 13521469335; Email: ohjerry@163.com
• Study Contact Backup: Name: Xue Yang Yang

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100176
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jie Li, PhD; Phone Number: 010-88196391; Email: xiaotong10241@sina.com

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

Single arm real world study of non-small cell lung cancer; stage IIIB or stage IV ALK positive NSCLC；

Description

Inclusion Criteria:

1. stage IIIB or stage IV NSCLC by histology or cytology;
2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment;
4. Voluntarily and capable of following the trial and follow-up procedures;
5. Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.

Exclusion Criteria:

• 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.

Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg).

6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.

7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer; Ensatinib 225mg QD Until the disease progresses or intolerance	Drug: Ensatinib; Prospective, exploratory, single-arm, multi-center, real-world research; Other Names: BD-EN-IV002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	2021.09.27-2024.12.30

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	2021.09.27-2024.12.30
Time-to-TreatmentFailure	2021.09.27-2024.12.30

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Betta Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2021
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): October 30, 2024

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this 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
• Other Study ID Numbers: BD-EN-IV002

Drug and device information, study documents

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