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

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called ensartinib as a neoadjuvant therapy for patients with operable or potentially operable ALK-positive lung adenocarcinoma, which is a type of advanced lung cancer. Neoadjuvant therapy means that the treatment is given before surgery, with the goal of shrinking the tumors and improving the chances of a successful operation. The trial aims to find out how effective and safe ensartinib is for patients with stage IIA to IIIB lung adenocarcinoma, a stage where the cancer is still treatable with surgery.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of lung adenocarcinoma that is classified as ALK-positive. They must also have tumors that can be surgically removed and meet specific health criteria. Participants can expect regular monitoring and assessments to evaluate the effectiveness of the treatment and their overall health. It's important to note that certain health conditions or previous treatments may exclude someone from joining the trial. This study is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Men and women of reproductive age agree to use a reliable method of contraception before entering the trial, during the study and up to eight weeks after discontinuation
• • Stable health status, including no acute exacerbations of chronic diseases, serious infections, or major surgeries during the first 4 weeks of enrollment, as indicated in other inclusion/exclusion criteria
• Exclusion Criteria:
• • 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