Non-small cell lung cancer
Conditions
Interventions
Case series:3 cycles of Nivolumab 4.5mg/kg +Paclitaxel (albumin-bound type) 260mg / m2 + Carboplatin AUC5 (21days+/- 3days interval)
and BiFico [4 pieces a time (0.21g/piece), twice per day]
Sponsors
Xiangya Hospital of 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 NSCLC have stage IIIA disease (according to AJCC 8th Edition), as well as stage IIIB NSCLC patients with potentially resectable locally advanced t3n2. 2. Patients with ECoG PS 0-1; 3. The patients aged 18 to 80 should sign the written informed consent; 4. Patients with appropriate treatment compliance and correct follow-up; 5. Patients with measurable or evaluable diseases (according to RECIST 1.1 standard); 6. Patients who must have the ability to swallow oral drugs.
Exclusion criteria
Exclusion criteria: 1. 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; 2. 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; 3. 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; 4. Patients with other active malignant tumors need to be intervened and / or received other research drugs or anti-cancer treatment at the same time; 5. 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; 6. 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; 7. Positive reaction of hepatitis B virus surface antigen (HBsAg) or hepatitis C virus RNA (HCV antibody) indicates acute or chronic infection; 8. Known HIV positive or acquired immunodeficiency syndrome (AIDS) patients; 9. Patients with a history of allergy to the study drug or ingredient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effects;Surgical complications and non-R0 surgical events; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Major Pathologic Response;1 and 2 years disease free survival;recurrence rate at 1 and 2 years; | — |
Countries
China
Contacts
Public ContactZhaoqian Liu
Xiangya Hospital of Central South University
Outcome results
None listed