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

NCT05132218 | Unknown

• 1 other identifier: BD-EN-IV002
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

ALK Positive; NSCLC Stage IIIB; NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  2021.09.27-2024.12.30

Secondary Outcomes (2)

• overall survival

  2021.09.27-2024.12.30

• Time-to-TreatmentFailure

  2021.09.27-2024.12.30

Study Arms (1)

Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer

Ensatinib 225mg QD Until the disease progresses or intolerance

Drug: Ensatinib

Interventions

Ensatinib DRUG

Prospective, exploratory, single-arm, multi-center, real-world research

Also known as: BD-EN-IV002

Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer

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

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100176, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. The patient's tumor tissue sample before taking Ensatinib 2. The patient's baseline blood sample within the first week before taking Ensantinib 3. Blood samples of patients 4-6 weeks after taking Ensatinib 4. Blood samples within 4 weeks after the patient's disease progression

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jun Zhao, PhD

CONTACT

13521469335; ohjerry@163.com

Xue Yang Yang

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 24, 2021
• Study Start: October 19, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2024
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)