Lung Cancer
Conditions
Interventions
single arm:camrelizumab plus platinum-based chemotherap
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, regardless of gender. 2. ECOG PS score of 0-1. 3. Diagnosed as non-small cell lung cancer confirmed by imaging and pathological histology, with a clinical stage of stage IIb-IIIb (according to AJCC TNM staging, 7th edition) as assessed by the investigator. 4. Suitable for radical resection and consent for standard surgical care. 5. No contraindications to surgery according to preoperative organ function evaluations. 6. No prior exposure to any systemic therapy for lung cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormonal therapy or immunotherapy 7. No planned neoadjuvant or adjuvant radiotherapy, chemotherapy, concurrent radiotherapy, etc. for lung cancer. 8. Laboratory test indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb) >= 90 g/L; white blood cell count (WBC) >= lower limit of normal; absolute neutrophil value (ANC) >= 1.5 x 10^9 /L; platelet count >= 100 x 10^9 /L. (2) Renal function: Cr = 40 ml/min. (3) Liver function: total bilirubin <= 1.5 x ULN; ALT and AST <= 3 x ULN. (4) Coagulation function: prothrombin time international normalized ratio <= 1.5 x ULN, and part of the prothrombin time within the normal range. (5) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. 9. Female patients of childbearing potential agree to use contraception for the duration of the study and for 6 months after study completion, have a negative serum or urine pregnancy test within 7 days prior to study entry, and are not breastfeeding; Male patients agree to use contraception for the duration of the study and for 6 months after study completion. 10. Subjects who can understand the study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are locally advanced unresectable diseases and metastatic diseases; 2. Any disease that requires corticosteroids (daily dose of prednisone or equivalent drugs> 10 mg) or other immunosuppressive drugs for systemic treatment has been suffered in the 14 days before randomization. Allow the use of topical replacement steroids (daily dose <= 10 mg of prednisone or equivalent drugs) and prescription corticosteroids for short-term (<= 7 days) prophylactic medication or for the treatment of non-autoimmune diseases. Suffer from any active autoimmune disease or history of autoimmune disease; 3. A history of active autoimmune diseases or autoimmune diseases that may recur. Allow entry for well-controlled type I diabetes, hypothyroidism that only requires hormone replacement therapy, well-controlled celiac disease, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or when there is no external cause Next are diseases that are not expected to recur. 4. History of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.). 5. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 6. Live vaccines have been vaccinated within 30 days before the first administration. Including but not limited to the following: mumps, rubella, measles, varicella/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); 7. Patients with uncontrolled cardiac clinical symptoms or diseases; 8. Those who are allergic to any of the drugs in this plan; 9. According to the judgment of the investigator, the subject has any medical history or current evidence of any disease, treatment, or laboratory abnormality that may confuse the test results, interfere with the subject's participation in the entire trial, or do not meet the subject's best interest in participating in the trial Subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response;Pathologic Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free Survival;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Wen
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed