Non-small Cell Lung Cancer
Conditions
Interventions
Experimental group:Camrelizumab+Albumin-Bound Paclitaxel
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically comfirmed resectable stage II-IIIA, including T2b-4 N0-1 or T0-4 N1 and T4 with no invasion of any organ (according to 8th Edition of American Joint Committee on Cancer (AJCC) TNM Staging System) NSCLC negative for driver genes; 2. Expected to undergo complete resection and agreeing to accept standard surgery after neoadjuvant treatment for tumor completely removal; 3. Untreated with any anti-cancer therapy; 4. Have at least one measurable target lesions examined by CT or MRI, with a maximum diameter of >=10 mm (if the target lesion is lymph node, its maximum short diameter should be >=15 mm) and receiving no prior radiation or other locally treatment, according to the RECIST v1.1 standard; 5. Aged between 18 and 80?years old at the time of signing the informed consent; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 7. Life expectancy >=6 months; 8. Adequate pulmonary for the prospective pneumonectomy; 9. Normal vital organs function without administration of any blood components or cell growth factors within 14 days conforming to the following standards: (1) Normal bone marrow defined as peripheral blood white blood cells (WBC) count >=4.0*10^9/L, platelet count (PLT) >=100*10^9/L and hemoglobin count (Hb) >=100 g/L; (2) Normal liver functions defined as total bilirubin (TBIL) <=1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5*ULN; (3) Normal renal functions defined as serum creatinine (SCr)<=50 mL/min. 10. Men and women of childbearing potential must agree to take adequate contraceptive measures during the entire study period and within 6 months after the completion of treatment; 11. Willing to participate this study, sign informed consent, comply with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Histology or cytology confirmed mixed subtype NSCLC, large cell neuroendocrine carcinoma and sarcomatoid carcinoma or NSCLC involving the superior sulcus; 2. Evidence of central nervous system (CNS) metastasis; 3. For patients with multiple primary lesions, there are no lesions with a solid component >=50%; 4. The target lesion has received chemotherapy, targeted therapy, endocrine therapy or local radiotherapy; 5. Previously received treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway); 6. Anaphylaxis to any study drug ingredient; 7. Participated in other clinical trials on anti-tumor drugs within 4 weeks before the first administration, or plan to receive live attenuated vaccines during the study period; 8. History of other malignant tumors in the last 5 years, excluding those with negligible risk of metastasis or death (expected disease-free survival> 5 years) and with expected radical curative results (for example, adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, and ductal carcinoma in situ treated by radical surgery; 9. Treated with immunosuppressant therapy within 14 days before receiving first dose of camrelizumab, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (ie no more than 10 mg/day prednisolone or other corticosteroids of equivalent pharmacological physiological dose); 10. At risk of acute life-threatening complications; 11. With active autoimmune disease or history of any autoimmune disease; 12. With grade II or above myocardial ischemia or myocardial infarction, or poorly controlled arrhythmia; 13. Complicated with severe infection within 4 weeks before the first administration (for example: intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever of >38.5 degree during the screening period or before the first administration of camrelizumab; 14. With a history of psychotropic drug abuse and unable to quit or with mental disorders; 15. Received major surgery within 4 weeks before the first administration, or with open wounds or fractures; 16. HIV infectors or replicators of hepatitis B or C virus; 17. Other conditions unsuitable to participate in this study determined by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response;Objective response rate;Event-free survival;Safety; | — |
Countries
China
Contacts
Public ContactKeneng Chen
Peking University Cancer Hospital
Outcome results
None listed