Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer

NCT06779539 | Not Yet Recruiting Phase 2

• 1 other identifier: CLOG-0003
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  pCR rate is defined as the proportion of participants who have achieved pathologic complete response (with no residual viable tumor in lung primary or lymph nodes as evaluated by central pathology laboratory of surgical specimens) in all participants.

  Within 2 month after surgery

Secondary Outcomes (5)

• Major Pathological Response (MPR) rate

  Within 2 month after surgery

• Objective Response Rate (ORR)

  Pre-operation

• Incidence of Adverse Events

  Up to 1 month after surgery

• Disease free survival (DFS)

  3 years postoperatively

• Overall Survival (OS)

  5 years postoperatively

Study Arms (1)

Ensartinib

EXPERIMENTAL

Drug: Ensartinib

Interventions

Ensartinib DRUG

Ensartinib 225 mg oral once daily 12 weeks

Ensartinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Give written informed consent before any study procedure.
• Male or female aged between 18 and 75 years old (including 18 and 75 years old).
• Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment.
• Clinical stage II-III assessed by EBUS-TBNA or PET/CT can be resected.
• Patients confirmed as ALK fusion positive by RBK (NGS) test.
• 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.
• Adequate hematological, biochemical and organ functions, defined as follows
• Hemoglobin ≥90g/L. Note: transfusions are allowed to meet the required hemoglobin level;
• Absolute neutrophil count (ANC) ≥1.5× 10\^9/L
• Platelets ≥90 × 10\^9/L;
• Total bilirubin ≤ 2 times the upper limit of normal (ULN)；
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;
• Creatinine ≤ 1.5× ULN and creatinine clearance ≥ 60 mL/min.
• Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis);

You may not qualify if:

• Mixed squamous cell carcinoma, large cell neuroendocrine carcinoma or small cell lung cancer;
• Prior treatment with any anti-cancer therapy;
• 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 CYP3A4 (at least 3 weeks prior). All patients must try to avoid using or ingesting any drugs, herbal supplements and/or foods that are known to have induced effects on CYP3A4.
• 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) or known human immunodeficiency virus (HIV). Screening for chronic diseases is not a requirement.
• 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 active or inactive excipients of Ensartinib or to drugs of similar chemical structure or class to Ensartinib, and uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow drugs, or had undergone major bowel resection that would interfere with adequate absorption of Ensartinib.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc)\>470 msec, obtained from 3 electrocardiograms (ECGs)
• Any 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.
• Any factors that increase the risk of QTc prolongation or the risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
• A clear past history of neurological or psychiatric disorders, including epilepsy or dementia；
• Other circumstances deemed inappropriate by the investigator for participation in the trial.

Sponsors & Collaborators

• West China Hospital: lead

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

Central Study Contacts

Qinghua Zhou

CONTACT

028-85422114; Prof._QH.Zhou_GCP@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgical Oncology and Molecular Biology

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 16, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 12, 2028
• Study Completion (Estimated): December 12, 2030
• Last Updated: January 17, 2025

Record last verified: 2025-01