Locally advanced lung cancer
Conditions
Interventions
Experimental Group:The study plans to enroll 15 patients with RET fusion-positive, unresectable stage IIIB/IIIC NSCLC confirmed by tissue or blood-based genetic testing. All patients will receive indu
Sponsors
West China Hospital of Sichuan Universit
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Before conducting any examination, sampling or analysis related to the research, the patient's written informed consent has been obtained. 2.Male or female, aged 18 to 75. 3. Primary lung glands confirmed by histology/cytology within 60 days prior to the study. 4. Locally advanced IIIB and IIIC stage NSCLC confirmed by histology or cytology and considered by the researchers as unsuitable for radical surgery, with measurable lesions (according to the RECIST 1.1 standard, the long diameter of tumor lesion CT scan is >=10mm, and the short diameter of lymph node lesion CT scan is >=15mm) The measurable lesion has not received local treatments such as radiotherapy or cryotherapy. 5. Positive RET fusion mutation is shown by tumor tissue or blood gene testing; 6. ECOG physical condition score: 0-1 point; 7. Female patients should take adequate and effective contraceptive measures, refrain from breastfeeding, and have a negative pregnancy test before the first administration of the investigational drug. Or female patients must meet the following criteria during screening to prove they are infertile: Postmenopause is defined as being over 50 years old and having no menstruation for at least 12 months after the cessation of all exogenous hormone therapy. For women under the age of 50, if there is no menstruation for 12 months or longer after the cessation of exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the postmenopausal range, it is considered postmenopausal. Documented irreversible sterilization surgeries, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, except for tubal ligation. 8. Male patients should be willing to use barrier contraception, that is, condoms
Exclusion criteria
Exclusion criteria: 1. Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma, or small cell carcinoma. 2. Genetic testing shows other driver gene mutations, including EGFR, ALK, and RET missense mutations. 3. Exposure to other antitumor treatments prior to enrollment. 4. Major surgery (including primary tumor surgery, excluding vascular access procedures) performed within 4 weeks before the first dose of the study drug. 5. Patients who are pregnant or breastfeeding. 6. History of other malignant tumors or currently concomitant with other malignant tumors (except for malignant tumors that have undergone radical surgery and have not recurred within 5 years after surgery, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma). 7. Severe or uncontrolled systemic diseases requiring treatment, which the investigator considers unsuitable for study participation, including hypertension, diabetes, chronic heart failure (NYHA class III-IV), unstable angina, myocardial infarction within 1 year, active bleeding disorders, hepatitis B (including all HBsAg positive patients), hepatitis C (HCV antibody positive), and human immunodeficiency virus (HIV); patients with active infections requiring intravenous treatment. 8. 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, history of major gastrointestinal resection, etc. 9. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring glucocorticoid treatment, or patients with clinical signs suspicious for interstitial lung disease. 10. Any of the following laboratory tests indicating 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 in the case of Gilbert syndrome (unconjugated hyperbilirubinemia) g) Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula) h) Prothrombin time (PT), International Normalized Ratio (INR), or activated partial thromboplastin time (aPTT) =1.5× ULN 11. Known or suspected allergy to pratinib or any other components. 12. Other conditions where the investigator considers that the patient cannot or should not participate in the study due to inability to comply with study procedures, restrictions, and requirements. 13. Patients currently or previously participating in any other antitumor clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Objectiv response rate;Pathological response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactDeng Hanyu
West China Hospital of Sichuan University
Outcome results
None listed