A single-center prospective exploratory single-arm neoadjuvant therapy study, based on a prospective cohort study, according to patients' blood and tumor samples before and after neoadjuvant treatment, WES, GEP gene expression profiling, TCR sequencing and ctDNA dynamic monitoring were used to explore the intratumoral immune consequences of PD-1 monoclonal antibody administration and identify potential Response biomarker.
Name: Durvalumab
Name: Albumin Paclitaxel
Name: Carboplatin/Cisplatin
Description: Major pathologic response is defined as the presence of 10% or less of vital tumor cells in the sections of the primary lesion and/or mediastinal lymph nodes presenting focal microscopic disease after surgery
Measure: MPR Time: At the date of tumor assessment after surgery, estimated at approximately 24 weeks post-baselineDescription: The progression free survival is the time until the patients disease progresses
Measure: Progression free survival Time: at 24 months from the first dose of neadjuvant treatmentDescription: Time when the patient is still alive
Measure: Overall survival Time: at 3 years from the first dose of neoadjuvant treatmentDescription: Toxicities caused by the drug during the study
Measure: Toxicity profile Time: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatmentAllocation: N/A
Single Group Assignment
There is one SNP
- The patient has a history of malignant tumors other than lung cancer - Patients with sensitive gene mutations in EGFR (E19del/E21 L858R) and ALK (various types of fusion mutations) Inclusion Criteria: - 18-80 years old - Male or female (no fertility requirement) - Meet NCCN lung cancer diagnostic criteria - No radical mastectomy, radiotherapy, chemotherapy, targeted therapy and immunotherapy - Resectable stage Ib-IIIa non-small cell lung cancer (NSCLC) patients confirmed by imaging and biopsy; clear lung histopathological sample results have been obtained during screening, and all molecular biological tests can be completed. --- L858R ---
- The patient has a history of malignant tumors other than lung cancer - Patients with sensitive gene mutations in EGFR (E19del/E21 L858R) and ALK (various types of fusion mutations) Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung To explore the safety and immunobiological effects of 2 cycles of duvalumab combined with albumin paclitaxel + cisplatin/carboplatin for patients with stage IB-IIIA non-small cell lung cancer; use whole exome sequencing , GEP gene expression profile detection based on NanoString platform and other methods to predict the efficacy of IMFINZI neoadjuvant therapy, looking for potential biomarkers; study the impact of neoadjuvant therapy of I drug on the tumor microenvironment at multiple levels such as genome, transcriptome, PD-1/PD-L1 protein transcription and expression, T cell TCR immune groupthe library and T cell subsets, and provide comprehensive exploratory research evidence for finding the biomarker for the neoadjuvant anti-PD-L1 therapy of lung cancer . --- L858R ---