Non-small cell lung cancer
Conditions
Sponsors
Institute of Clinical Pharmacology, Xiangya Hospita Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with previously untreated NSCLC and histologically or cytologically proven, have stage IIIA disease (according to AJCC 8th Edition), as well as stage IIIB NSCLC patients with potentially resectable locally advanced T3N2; 2. The multidisciplinary team (MDT) should consider including subjects with the tumor could be completely resected; 3. Patients with ECoG PS 0-1; 4. laboratory values should be obtained within 14 days and must meet the following criteria: Neutrophils>=1500*10^9/L; Platelets>=100*10^9/L; Hemoglobin>9.0g/dL; Serum creatinine=40 mL/min; AST/ALT=1.2 liters or >40% predicted value. INR/APTT is within the normal range; 5. Before any trial-related intervention, all patients should be informed of the research nature of all studies and sign written informed consent in accordance with institutional and national guidelines (including the Declaration of Helsinki); 6. > 18 years old, subjects must have the ability to swallow oral drugs; 7. Women of childbearing potential, including women with the last menstrual period in the last two years, must have a negative serum or urine pregnancy test within 7 days. All males and females of childbearing potential must use an effective method of contraception (two barrier methods or a barrier method plus a hormone method) during study treatment and for at least 12 months after the last dose of the investigational drug; 8. Subjects with appropriate treatment compliance could be followed up; 9. Subjects with measurable or evaluable diseases (according to RECIST 1.1 standard); 10. Subjects without contraindications to colonoscopy, such as suspected intestinal perforation, acute diverticulitis or fulminant colitis.
Exclusion criteria
Exclusion criteria: 1. Any subject with EGFR activating mutation or ALK gene mutation; 2. Subjects with active, known or suspected autoimmune diseases. Subjects with vitiligo, type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or unexpected recurrence without external triggering were allowed to be included; 3. Patients requiring systemic treatment with corticosteroids (daily equivalent dose of prednisone > 10 mg) or other immunosuppressive drugs within 14 days after enrollment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement steroid doses greater than 10 mg prednisone per day are permitted; 4. Patients with symptomatic ILD (grade 3-4) and / or poor pulmonary function and a history of interstitial lung disease cannot be included. If you have any questions, please contact the trial team; 5. Patients with other active malignant tumors need to be intervened and / or received other research drugs or anti-cancer treatment at the same time; 6. Patients with previous malignancies (except non-melanoma skin cancer, carcinoma in situ of the following: bladder cancer, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer); 7. Patients whose researchers believe that due to any medical, mental or psychological condition, they are unable to complete the study or understand the informed consent of the patients; 8. Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies or any other antibodies or drugs targeting T cell costimulation or immune checkpoint pathway; 9. Positive reaction of hepatitis B virus surface antigen (HBsAg) or hepatitis C virus RNA (HCV antibody) indicates acute or chronic infection; Known HIV positive or acquired immunodeficiency syndrome (AIDS) patients; 10. Patients with a history of allergy to the study drug or ingredient; Women who are pregnant or breastfeeding; Men and women of potential fertility, and subjects who are reluctant to use effective contraception for sexual activity during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene variants information;Dual source perfusion CT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Major Pathologic Response;Disease free survival rate;Recurrence rate; | — |
Countries
China
Contacts
Public ContactZhaoqian Liu
Xiangya Hospital of Central South University
Outcome results
None listed