Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study

NCT06785584 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024ENT01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer. Surgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients. In the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients. Many studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC. The investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma

Conditions

ALK-positive Advanced NSCLC; ALK-positive Non-small Cell Lung Cancer (NSCLC); MPR; Neoadjuvant Therapy

Keywords

Ensartinib; Neoadjuvant Therapy; ALK-Positive Lung Adenocarcinoma; MPR

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate(MPR)

  The proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after completion of neoadjuvant therapy

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Pathological complete response rate (pCR)

  From enrollment to the end of treatment at 8 weeks

• Objective Response Rate (ORR)

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Ensartinib For Neoadjuvant Therapy

EXPERIMENTAL

receive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity

Drug: Ensartinib

Interventions

Ensartinib DRUG

receive neoadjuvant treatment with ensartinib 225 mg once a day, po. for 2 consecutive cycles (56 days) to evaluate possibility of surgery, or discontinue the treatment because of disease recurrence or intolerable toxicity

Ensartinib For Neoadjuvant Therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18
• Histologically or cytologically confirmed lung adenocarcinoma
• Evaluated resectable TNM stage IIA-IIIB (operable or potentially operable) non-small cell lung cancer (NSCLC)
• Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods，before treatment with ALK inhibitors
• Measurable lesions were determined with the use of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria) on CT scans
• Magnetic resonance imaging (MRI) or CT scans of the brain show no metastatic disease
• Tumors contained components of squamous cell carcinoma, large-cell neuroendocrine carcinoma, or small-cell carcinoma
• Severe infections, including COVID-19, including but not limited to hospitalization due to complications of infection within the 4 weeks prior to starting study treatment
• Have not received chemotherapy, radiotherapy, or biological therapy
• Hemoglobin ≥100 g/L(which can be maintained or exceeded by blood transfusion); Absolute neutrophil count ≥2.0×109/L; Platelet count ≥100×109/L
• Total bilirubin ≤1.5 times upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; CREA ≤1.5 times the upper limit of normal and CREA clearance ≥60mL/min
• Women of childbearing age (15 to 49 years) must undergo a urine pregnancy test within 7 days before starting treatment and the result is negative
• Informed consent is obtained from patients or their legal representatives
• Able to swallow oral medications normally
• ECOG behavior status score is 0 to 1

You may not qualify if:

• Have received any systemic anti-cancer treatment for locally advanced non-small cell lung cancer, including chemotherapy, biotherapy (including ALK-TKI), immunotherapy, or any investigational drug
• PET-CT scan or biopsy results showing unresectable stage III and IV disease with distant metastasis (including malignant pleural effusion)
• Patients who had a cancer other than NSCLC within 5 years before the initiation of study treatment
• Allergy to ensartinib or any of the ingredients in this product
• Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;Baseline CT scans found idiopathic pulmonary fibrosis
• Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow preparations, or previous major bowel resection resulting in inadequate absorption of ensartinib
• Any unstable systemic illness, including active infection, uncontrolled hypertension, unstable angina, angina with onset within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] class II), myocardial infarction (within 6 months before enrollment), severe arrhythmias requiring medical therapy, or hepatic, renal, or metabolic disease
• Human immunodeficiency virus (HIV) infection
• Pregnant or lactating women
• A definite past history of neurological or psychiatric disorders, including epilepsy or dementia
• History of organ transplantation
• Rheumatic immune-related diseases
• Other cases that the researcher deemed unsuitable for enrollment

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350100, China

Location

MeSH Terms

Interventions

ensartinib

Central Study Contacts

Guanglei Huang

CONTACT

+86 18059776417; 1318718218@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: January 21, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)