non-small cell lung cancer
Conditions
Interventions
Treatment group:Oral Iruak 60mg QD x 7d?180mg QD every 4 weeks for a total of 8 weeks.
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the study and sign the informed consent; 2.18-75 years old; 3. Histologically proven non-small cell lung cancer (NSCLC). 4. Stage II-IIIA or IIIB (T3N2 only) ALK-positive or RoS1-positive NSCLC assessed by investigators (AJCC 8th edition). 5. Complete surgical removal of primary NSCLC by MDT assessment, which should include a thoracic surgeon specializing in oncology surgery, is achievable. 6. The ECOG performance status is 0-1. 7. At least one measurable lesion according to RECIST1.1. 8. Can swallow pills normally; 9.The function of vital organs meets the following requirements (no blood component, cell growth factor drugs are allowed to be used within 14 days before the first drug) : ? Absolute neutrophil count =1.5×10^9/L; ? Platelet =100×10^9/L; ? Hemoglobin =90 g/L; ? Serum albumin =30 g/L; ? Serum total bilirubin =1.5×ULN; ? ALT and AST= 2.5×ULN, if there is liver metastasis, ALT and AST=5ULN; ? AKP= 2.5 x ULN; ? serum creatinine =1.5×ULN; ? International Standardized ratio (INR) =1.5×ULN (not receiving anticoagulant therapy); 10.Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of childbearing age who have been sterilized without surgery within 7 days prior to the first dose. And must be non-lactation period; For male patients whose partner is a woman of reproductive age, effective contraception should be used during the trial and within 3 months after the last dose of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Patients who are participating in another clinical study or receiving another investigational drug, or who received the investigational device within 4 weeks prior to the first dose of our investigational drug. Patients may be included in this study if they are participating in a non-interventional clinical trial. 2.Have previously received any systemic anti-cancer treatment for NSCLC, including chemotherapy, biotherapy, immunotherapy, or any investigational drug. 3. Previous treatment with ALK TKI or ROS1 TKI. 4. Previously received local radiotherapy. 5. Mixed small cell and NSCLC histology. 6. Suitable for patients undergoing segmentectomy or cuneiform resection only. 7. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 8. Other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years or at the same time; 9.Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; Hypertensive crisis or hypertensive encephalopathy in the past; 10.Have clinical symptoms or diseases that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, (5) QTc>450ms (male); QTc>470ms (female); 11.Patients with pleural effusion, ascites, or pericardial effusion requiring drainage can be enrolled if their symptoms are assessed to be stable after drainage. 12.Have a congenital or acquired immune deficiency (such as HIV infection); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) =2000 IU/ml, or hepatitis C virus antibody positive; 13.Live vaccine was administered less than 4 weeks before or possibly during the study period; 14.The presence of active gastrointestinal (GI) disease or other conditions that significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug. 15.According to the investigators' judgment, the patients had other factors that might affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, and family or social factors that would affect the safety of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; R0 resection rate;Objective remission rate;Disease control rate;Event-free lifetime;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactLi Wei
Henan Provincial People's Hospital
Outcome results
None listed