non-oncogene addicted advanced/locally advanced non small cell lung cancer
Conditions
Interventions
Platinum-containing combined chemotherapy and PD-1 monoclonal antibody were applied on the first day of each cycle (repeated every 3 weeks):none
Platinum containing combination chemotherapy was applied on the first day (D1), and PD-1 monoclonal antibody was applied on the third day of each cycle (D3) (repeated every 3 weeks):none
PD-1 monoclonal antibody was applied on the first day (D1), platinum containing combined chemotherapy on the second and third days (d2-d3) (repeated every 3 weeks):none
Sponsors
Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Patients with histologically or cytologically confirmed diagnosis of NSCLC, and the results of sputum cytology should be confirmed by immunohistochemistry of cell sediment; ? The clinical staging based on imaging is stage III/IV (according to the AJCC 8th edition lung cancer staging criteria), and stage III requires confirmation from the radiotherapy department that curative concurrent chemoradiotherapy cannot be performed; ? Detection of EGFR/ALK/ROS-1/RET/BRAF V600E/MET 14exon peeling by tissue or body cavity fluid testing is negative (considering false negative issues, blood ctDNA testing is not accepted); ? Patients with NSCLC who have received surgery or radical radiotherapy and are confirmed by MDT as unsuitable for local treatment after recurrence or metastasis. The end time of adjuvant therapy (chemotherapy and immunization) is required to be more than 6 months after the first administration of this study, and all kinds of toxic reactions caused by adjuvant therapy must have resolved to baseline or = CTCAE Grade 1 (with the exception of alopecia); ? Eastern Cooperative Oncology Group (ECOG) performance status 0-1; ? Patients must be at least one lesion that can be accurately measured and evaluated at baseline according to the response evaluation criteria in solid tumours 1.1 (RECIST 1.1) criteria, who has not received local treatment such as radiotherapy, and has not undergone biopsy during screening. The longest diameter at baseline is = 10mm (lymph node short diameter = 15mm); ? Patients must have fully understood and voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: ? The pathological results were returned to NSCLC with mixed tumor components; ? Feasibility of synchronous chemoradiotherapy for stage III NSCLC; ? EGFR/ALK/ROS-1/RET/BRAF V600E/MET 14exon skinning positive; ? Brain/meningeal metastasis; ? At the beginning of the study, in addition to the grade 2 neurotoxicity caused by hair loss and previous chemotherapy, the unreduced residual toxicity caused by previous treatment was greater than CTCAE grade 1; ? Any serious or poorly controlled systemic disease identified by researchers, such as active infections or active autoimmune diseases; ? Insufficient bone marrow reserve or organ function, reaching the following laboratory limits; 1)Absolute neutrophil count 1.5 × ULN, creatinine clearance rate<50 mL/min (calculated according to the Cockcroft Gault formula); The creatinine clearance rate only needs to be confirmed when creatinine is greater than 1.5 × ULN; ? Lactating women; ? History of allergies to research drugs or similar medications; ? The patients identified by the researchers have poor compliance with the research procedures and requirements; ? The patient identified by the researcher as having any situation that endangers patient safety or interferes with the study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| depth of response,DPR;disease control rate,DCR;overall survival, OS;safety; | — |
Countries
China
Contacts
Public ContactFeng Xue
Affiliated Hospital of Guilin Medical University
Outcome results
None listed