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A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer

NCT05380024•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This is a Phase II, single-Arm, prospective study of neoadjuvant Ensartinib for the treatment of patients with ALK positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
•Male or female, at least 18 years of age.
•Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
•Clinical stage IIA/IIB/IIIA/IIIB assessed by EBUS-TBNA or PET(positron emission tomography)/CT can be resected.
•Patients confirmed as ALK positive (FISH or Ventana IHC or RT-PCR, NGS)
•Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements.
•Eastern Cooperative Oncology Group (ECOG) performance status （PS） of 0 or 1 at enrolment.
•Hematology , liver and kidney function are adequate for neoadjuvant therapy.
•Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis).
•Serum pregnancy test (for females of childbearing potential) negative at screening.Female patients of non-childbearing potential must meet at least 1 of the following criteria:
+4 more criteria

Exclusion Criteria

•Mixed squamous cell carcinoma, large cell carcinoma，small cell lung cancer.
•Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
•Pregnant female patients; breastfeeding female patients.
•Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of Cytochrome P450 3A4(CYP3A4)(at least 3 weeks prior).
•Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (e.g., in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
•Past medical history of Interstitial lung disease（ ILD）, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
•A history of hypersensitivity to Icotinib with or without active excipients or to drugs of similar chemical structure or class, and uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated drugs, or having undergone major bowel resection that would interfere with adequate absorption of Ensartinib.
•Any of the following cardiac criteria:
•①Mean resting corrected QT interval (QTc)\>470 msec, obtained from 3 electrocardiograms (ECGs)
•②Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \>250msec, symptomatic bradycardia \<45 beats/minute.
+3 more criteria

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

NAN Wu

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 17, 2022

Primary Completion Date

December 30, 2023

Completion Date

June 30, 2024

Last Updated

August 18, 2022

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

Ensartinib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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