non-small cell lung cancer
Conditions
Interventions
A:Non-squamous cell carcinoma: Pembrolizumab + platinum + Pemetrexed. squamous cell carcinoma: Pembrolizumab+nab-paclitaxel+platinum
B:Pembrolizumab
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with advanced (stage IV) or recurrent NSCLC confirmed by histopathology or cytology according to AJCC TNM stage (8th edition); 3. There is at least one measurable lesion according to RECIST 1.1 standard, and the lesion has not received radiotherapy; 4. The patient has not received systematic treatment before; 5. Patients with positive EXPRESSION of PD-L1 (TPS>=1%) who were provided with detectable tissue samples before enrollment and confirmed by the central laboratory; 6. Patients with negative EGFR-sensitive mutation and ALK fusion gene test results by genetic testing; 7. ECOG score 0-1, and the expected survival time is more than 3 months; 8. Patients may have a history of brain/meningeal metastasis, but must undergo local treatment (surgery/radiotherapy) prior to study initiation and be clinically stable for at least 1 month (corticosteroid administration prior to the first administration of the study drug is permitted, but discontinued 2 weeks prior to the commencement of study drug administration); 9. Functional reserve of vital organs meets the following requirements: Routine blood tests: (no blood transfusion, no g-csf or other cytogenetic drug correction treatment within 2 weeks before screening); Hemoglobin (HB) >=90 g/L; Absolute value of neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >= 90 x 10^9/L; WBC >= 3.0x10^9/L and =60mL/min (Cockcroft-Gault formula); TSH <=1 ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if NORMAL, FT3 and FT4 levels can be included in the group); APTT <= 1.5 ULN, and INR or PT<=1.5 ULN (no anticoagulant therapy). 10. No autoimmune diseases; 11. Subjects voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Having other malignant tumors at the same time; 2. The investigator determined that the patient had other serious diseases that might affect follow-up and short-term survival; 3. Patients with EGFR-T790m drug-resistant mutation and ALK rearrangement according to gene detection results; 4. Presence of definite peripheral nerve disease; 5. Other researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS;OS;TRAE; | — |
Countries
China
Contacts
Public ContactGuanghui Gao
Shanghai Pulmonary Hospital
Outcome results
None listed