Drug-resistant non-small cell lung cancer
Conditions
Interventions
Trial group:Chemotherapy guided by micro-tumor sensitivity test combined with Pitavastatin Calcium Tablets:
1. Study Drug: Pitavastatin Calcium Tablets
Name: Pitavastatin Calcium Tablets
Dosage: 4 mg
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Age: >= 18 and = 10 mm; lymph node lesions must have a CT scan short diameter of >= 15 mm; scan slice thickness should not exceed 5 mm; and measurable lesions must not have undergone local treatments such as radiotherapy or cryotherapy. 5. ECOG Performance Status: 0–2 points. 6. Expected survival period of at least 6 months. 7. Hematological function is considered sufficient, defined as an absolute neutrophil count >= 1.5 × 10^9/L and an adequate platelet count. Number >= 80 × 10^9/L, hemoglobin >= 90 g/L (no history of blood transfusion within the past 7 days, and not corrected with G-CSF or other hematopoietic stimulating factors); 8. Adequate liver function is defined as having total bilirubin levels = 50 mL/min (calculated using the Cockcroft-Gault formula); 10. Adequate coagulation function is defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal to 1.5 times the upper limit of normal (ULN). If the subject is receiving anticoagulant therapy, coagulation function is considered adequate as long as the INR/PT values fall within the therapeutic range specified for the anticoagulant medication. 11. For female subjects of childbearing age, a negative urine or serum pregnancy test must be conducted within three days prior to the first administration of the study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. 12. If there is a risk of conception, male and female patients should use highly effective contraception (i.e., methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method. 13. The subjects voluntarily joined this study, signed a written informed consent form before any trial-related procedures were implemented, demonstrated good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Individuals known to be allergic to the active or inactive ingredients of pitavastatin, or to drugs with chemical structures similar to pitavastatin. 2. Individuals with known allergies to pemetrexed, paclitaxel, gemcitabine, or platinum. 3. Active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction requiring clinical intervention. 4. Symptomatic, uncontrolled brain metastases or leptomeningeal metastases, or controlled brain metastases with symptoms lasting less than 2 months. 5. Diagnosed with malignant tumors other than small cell lung cancer within two years prior to enrollment, excluding completely treated basal or squamous cell skin cancer and/or radically resected in situ cancer. 6. Has undergone major surgery within the 4 weeks prior to the start of the study or has experienced complications or sequelae that have not yet resolved. 7. Suffering from serious or uncontrolled illnesses, including but not limited to the following: Uncontrollable nausea and vomiting, inability to alleviate symptoms of intestinal obstruction, inability to swallow study medications, and any gastrointestinal diseases that may interfere with drug absorption and metabolism. (1) Patients with respiratory syndrome caused by pleural effusion or ascites (>= CTCAE grade 2 dyspnea) (2) Active viral infections such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), etc. (3) Uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that impair the patient's ability to provide informed consent. 8. Having a tendency to bleed and a history of thrombosis. (1) Any bleeding events of CTCAE grade 2 occurring within the first 3 months of screening, or bleeding events of CTCAE grade 3 or higher occurring within the first 6 months of screening. (2) Active bleeding, coagulation dysfunction, bleeding tendency, or current treatment with thrombolytic or anticoagulant therapy. (3) The patient requires anticoagulant therapy with medications such as warfarin or heparin. (4) Patients require long-term antiplatelet therapy, such as aspirin or clopidogrel. (5) Thrombotic or embolic events have occurred within the past six months, including cerebrovascular accidents (such as transient ischemic attacks) and pulmonary embolism. 9. Significant cardiovascular history: (1) NYHA (New York Heart Association) Class III and IV congestive heart failure (2) Screening for unstable angina, newly diagnosed angina, or myocardial infarction within the previous 12 months. (3) Arrhythmia requiring therapeutic intervention (patients taking beta blockers or digoxin may be enrolled) (4) CTCAE Grade >= 2 valvular heart disease (5) Poor control of hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) 10. History of non-infectious pneumonia requiring corticosteroid treatment within one year prior to enrollment, or a current diagnosis of non-infectious pneumonia. 11. Any past or current diseases, treatments, or laboratory abnormalities that may interfere with the research results, affect the patient's full participation in the study, or lead the researcher to believe that the patient is unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Laboratory tests, vital signs, and other safety assessments;Adverse event;Duration of Relief (DoR);Progression-free survival (PFS);Overall Survival (OS);Overall survival period; | — |
Countries
China
Contacts
Public ContactChen Chang and Su Hang
Shanghai Pulmonary Hospital
Outcome results
None listed