Locally advanced lung cancer
Conditions
Interventions
Experimental Group:The study will recruit 43 cases of ALK fusion-positive NSCLC patients who have been diagnosed through tissue or blood gene testing and are in the unresectable stage IIIA/IIIB/IIIC.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following eligibility criteria: 1. Written informed consent was obtained from the patient before any examination, sampling, or analysis related to the study was performed. 2. Male or female, aged 18-75 years. Primary lung adenocarcinoma confirmed histologically/cytologically within 60 days prior to study. 4. Confirmed by histology and cytology, and the researchers consider not GeXing radical surgery or discomfort locally adanced IIIB, IIIC NSCLC, with a measurable lesions (according to the RECIST1.1 standard, tumor lesion on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or more, Measurable lesions had not received local treatment such as radiotherapy and cryotherapy). 5. ALK fusion mutation was detected in tumor tissue or blood. 6. The subject has received alectinib monotherapy for no more than 6 months; 7. Previous asymptomatic brain or meningeal metastases (e.g., incidentally diagnosed at study baseline) were allowed. Asymptomatic central nervous system lesions could be treated at the discretion of the investigator according to local practice. Patients with neurologic symptoms or signs due to CNS metastases are required to complete whole-brain radiotherapy or gamma knife irradiation. Radiation therapy had to be completed at least 14 days before enrollment, and patients were required to be clinically stable. 8. ECOG performance status score 0-1; 9. Female patients should use adequate and effective contraception, not breast-feed, and have a negative pregnancy test before the first dose of the study drug; Or female patients at screening must meet the following criteria to demonstrate infertility: (1) Postmenopausal, defined as older than 50 years with no menses for at least 12 months after stopping all exogenous hormone therapy. (2) Women younger than 50 were considered postmenopausal if they had not had menorrhea for 12 months or more after stopping exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels were in the postmenopausal range. (3) Documented irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, with the exception of tubal ligation. 10. Male patients should be willing to use barrier contraception, namely condoms (see Section 4.5).
Exclusion criteria
Exclusion criteria: 1. Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma or small cell carcinoma. 2. Other driver gene mutations exist in genetic testing, including EGFR, ROS1 and RET mutations, etc. 3. Within 4 weeks before the first administration of the study drug, major surgery (including primary tumor surgery, excluding vascular pathway establishment operations) has been performed. 4. The patient is in pregnancy or lactation period. 5. Has a history of other malignant tumors, or is currently suffering from other malignant tumors (excluding malignant tumors that have undergone radical surgery and have not relapsed within 5 years, such as cervical adenocarcinoma, basal cell carcinoma of the skin and papillary thyroid carcinoma, etc.). 6. Has severe or uncontrolled systemic diseases that require treatment, and the investigator considers the patient unsuitable for participation in the trial, including hypertension, diabetes, chronic heart failure (NYHA cardiac function classification III-IV), unstable angina pectoris, myocardial infarction within 1 year, active bleeding, etc.; hepatitis B (including all HBsAg positive patients), hepatitis C (HCV Ab positive) and human immunodeficiency virus (HIV); patients with active infections requiring intravenous drug treatment; 7. Have severe gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug, such as inability to take oral medication, uncontrollable nausea and vomiting, extensive history of gastrointestinal resection, etc. 8. Have a history of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, etc., or have clinical manifestations suspicious of interstitial lung disease. 9. Any of the following laboratory tests indicate insufficient bone marrow or organ reserve function: a) Absolute neutrophil count 2.5 × upper limit of normal (ULN) e) Aspartate aminotransferase (AST) > 2.5 × ULN f) Total bilirubin > 1.5 × ULN or > 3 × ULN when having Gilbert syndrome (non-conjugated hyperbilirubinemia) g) Creatinine clearance rate = 1.5 times ULN 10. Known or suspected allergic to alpelisib or other components. 11. If the patient cannot follow the study procedures, restrictions and requirements, the investigator considers that the patient is not eligible or unsuitable for participation in the study in other circumstances. 12. Patients who have participated in any other anti-tumor clinical studies currently or in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Pathological response rate;Pathological downstaging rate;Overall survival; | — |
Countries
China
Contacts
Public ContactDeng Hanyu
West China Hospital of Sichuan University
Outcome results
None listed