ALK-positive non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment group:Ensartinib + Chemotherapy
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Provide informed consent before any specific study procedures are carried out. 2. Be between 18 and 75 years of age, inclusive. 3.Have a histologically or cytologically confirmed diagnosis of lung adenocarcinoma based on a biopsy performed within 60 days prior to study enrollment. 4.Have operable stage II - IIIB (N2) lung adenocarcinoma (AJCC 9th edition TNM staging). 5. Be confirmed to have ALK fusion mutations by detection methods recommended by the NCCN guidelines. 6. Have at least one accurately measurable lesion. At baseline, computed tomography (CT) should show a longest diameter of >=10 mm (or lymph nodes with a short axis of >=15 mm), and the lesion should be suitable for accurate repeated measurement. 7.Have an ECOG performance status of 0 - 1. 8. Have the following hematological, biochemical, and organ functions: a. Hemoglobin >=90 g/L (can be maintained by blood transfusion or exceed this level). b. Absolute neutrophil count >=1.5×10^9/L. c. Platelet count=60 mL/min. 9. Have cardiopulmonary function suitable for surgical treatment (as assessed by ECG, echocardiography, pulmonary function tests, or blood gas analysis). 10. Female subjects should use highly effective contraceptive measures at least 2 weeks before starting the study drug, have a negative pregnancy test, and not be breastfeeding at the time of starting the administration. Or they must meet one of the following criteria at the time of screening to prove the unlikely possibility of fertility: a. Post - menopausal, defined as being over 50 years of age and having amenorrhea for at least 12 months after stopping all exogenous hormone therapy. b. Women under 50 years of age who have had amenorrhea for 12 months or longer after stopping exogenous hormone therapy and have luteinizing hormone (LH) and follicle - stimulating hormone (FSH) levels within the post - menopausal range should be considered post - menopausal. c. Irreversible surgical sterilization documented by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation. 11. For male subjects whose partners are of child - bearing potential, they should agree to use effective contraceptive methods during the study and for 3 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or small cell carcinoma components. 2.Prior exposure to other anti-tumor therapies before enrollment. 3. Pregnancy or lactation in the patient. 4. Currently taking (or unable to discontinue use before the first dose of the study treatment) drugs or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior). All patients must avoid concomitant use or intake of any drugs, herbal supplements, and/or foods known to have an inducing effect on CYP3A4 as much as possible. 5. Evidence of any severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding. The investigator considers any condition that is unfavorable for the patient's participation in the study or compromises compliance with the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic diseases is not required. 6. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of active interstitial lung disease. 7. History of hypersensitivity to active or inactive excipients of ensartinib or drugs with similar chemical structures or classes as ensartinib, as well as uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated medications, or having undergone major intestinal resection surgery that would prevent adequate absorption of ensartinib. 8. Intolerance to chemotherapy or disagreement with chemotherapy. 9. Any of the following cardiac criteria: a. The average resting corrected QT interval (QTc) obtained from 3 electrocardiogram (ECG) examinations using the QTc value measured by the screening diagnostic electrocardiograph is > 470 milliseconds. b. Any clinically significant rhythm, conduction, or morphological abnormalities on the resting electrocardiogram, such as left bundle branch block, third-degree heart block, and second-degree heart block. c. Any factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medications known to prolong the QT interval. 10. A clear history of neurological or psychiatric disorders, including epilepsy or dementia. 11.Other conditions that the investigator considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR);The impact of baseline ALK fusion with concurrent gene co - mutations on the efficacy of neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR);Objective response rate (ORR);R0 resection rate;3 - year event - free survival (EFS) rate;Event - free survival (EFS);5 - year overall survival (OS) rate;Overall survival (OS);10 - year overall survival (OS) rate; | — |
Countries
China
Contacts
Public ContactXiaoLong Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed