Non-small cell lung cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Patients with pathological diagnosis of stage IIIB-IV NSCLC plan to receive immunotherapy; 3. Patients diagnosed with stage IIIB-IV NSCLC have not received any immunotherapy since; 4. Patients who have received pre-adjuvant neoadjuvant chemotherapy or post-operative adjuvant chemotherapy should meet the requirements for more than 6 months (including 6 months) of completed treatment; 5. The Eastern Cooperative Oncology Group (ECOG) physical performance score is 0 or 2 and did not deteriorate in the previous 2 weeks, with a minimum expected survival of 12 weeks; 6. The patient has at least one tumor lesion that has not undergone local treatment such as irradiation, and has not received a tissue biopsy during the screening period, and can be accurately measured at the baseline. Diameter >=15 mm). The selected measurement method is suitable for accurate and repeated measurements, which can be computed tomography (CT) or magnetic resonance scanning (MRI). If there is only one measurable lesion and no previous local treatment such as irradiation, it can be accepted as the target lesion, and the baseline evaluation of the tumor lesion must be performed at least 14 days after the diagnostic biopsy; 7. Women of childbearing age should take appropriate contraceptive measures 3 months after screening to stop study treatment and should not breastfeed. Before starting the dosing, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy: (1) Postmenopausal is defined as amenorrhea for at least 12 months after the age of more than 50 years and after stopping all exogenous hormone replacement therapy; (2) For women younger than 50 years of age, if all amenorrhea treatment is stopped after 12 months or more, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the reference values of laboratory postmenopausal Can be considered post-menopausal; (3) Have undergone irreversible sterilization, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, except for bilateral tubal ligation; 8. Male patients should use barrier contraception (ie condoms) 3 months after screening to stop study treatment. 9. The subjects themselves voluntarily participated and signed an informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Any previous immunotherapy (PD-1 / PD-L1 inhibitor); 2. Patients with other malignant tumors, except skin basal cell carcinoma and carcinoma in situ; 3. At the beginning of the study treatment, there was greater than CTCAE grade 1 residual toxicity of previous treatment that failed to be relieved, except for hair loss and grade 2 neurotoxicity caused by previous chemotherapy; 4. Spinal cord compression or brain metastasis, unless asymptomatic, the condition is stable, and steroid therapy is not required at least 2 weeks before the first dose of study treatment; 5. According to the investigator's judgment, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active susceptible to bleeding constitution or active infection. No need to troubleshoot chronic diseases; 6. Meets any of the following cardiac examination results: (1) The average corrected QT interval (QTc) (QTc)> 470 msec derived from three electrocardiogram (ECG) examinations at rest, using the Fridericia formula for QT interval correction (QTcF); (2) Resting ECG suggests the presence of various clinically significant rhythms, conduction or ECG morphological abnormalities (eg, complete left bundle branch block, 3 degree AV block, 2 degree AV block, and PR interval Period> 250 msec); (3) There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or extended QT of immediate relatives under 40 Any combined medication in the interval; (4) Left ventricular ejection fraction (LVEF) 2.5 times the upper limit of normal (ULN); if there is liver metastasis, alanine aminotransferase> 5 ULN; (5) If there is no clear liver metastasis, aspartate aminotransferase> 2.5 ULN; if there is liver metastasis, aspartate aminotransferase> 5 ULN; (6) If there is no clear liver metastasis, total bilirubin> 1.5 ULN; or Gilbert syndrome (unconjugated hyperbilirubinemia) or liver metastasis, total bilirubin> 3 ULN; (7) Creatinine> 1.5 ULN and creatinine clearance 1.5 ULN; 11. Women who are breastfeeding or have a positive blood or urine pregnancy test within 3 days before the first dose of study treatment; 12. Have a history of drug allergies; 13. Patients who have been determined by the investigator to have poor compliance with the study procedures and requirements; 14. The investigator judges that there are any patients who endanger the safety of the patient or interfere with the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18F-FDG-PET / CT parameters;the objective response rate of immunotherapy;immune-related toxicity;overall survival;progression free surwival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate; | — |
Countries
China
Contacts
Public ContactJun Wang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed