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

NSCLC Stage IV Clinical Trial

— EFLRWR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132218
• Other study ID #: BD-EN-IV002
• Status: Recruiting
• Start date: October 19, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2021
• Source: Beijing Cancer Hospital
• Contact: Jun Zhao, PhD
• Phone: 13521469335
• Email: ohjerry[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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;

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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALK Positive
• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IIIB
• NSCLC Stage IV

Intervention

Drug:
• Ensatinib
Prospective, exploratory, single-arm, multi-center, real-world research

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2021.09.27-2024.12.30
Secondary	overall survival		2021.09.27-2024.12.30
Secondary	Time-to-TreatmentFailure		2021.09.27-2024.12.30