This study aims to investigate the efficacy and safety of targeted therapy and chemotherapy±immunotherapy as neoadjuvant therapy in stage IIB-IIIB NSCLC patients.(observational study)
This is an open, observational clinical study, 2-3 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage IIB-IIIB. Study design: Newly diagnosed Resectable IIB-IIIB NSCLC EGFR/ALK/ROS1 TEST PD-L1 TEST Collect puncture biopsy tissue/ Blood sample in screening period Chest enhanced CT Conditions allowed, whole body PETCT Exam; Group A:Targeted therapy Tumors with Driver genes (EGFR/ALK/ROS1 Positive) 2 cycles(42 days; Group B:Immunotherapy Enroll Patients from 816 Research treated with Neoadjuvant immunotherapy Or, treated with immunotherapy in practice(with approval) Group C:Routine Chemotherapy Driver genes(EGFR/ALK/ROS1 Negative) and PD-L1 Test negative or unknown; Operation (within 6 Ws postoperation) Standard treatment, Allow adjuvant chemotherapy±radio therapy Collect resected tissue sample(Tumor T and Node N) /Blood sample; comparisons before and after treatment: Imaging:CT、PET-CT Sample:Tumor tissue、blood Objective and End point: 1. Main objective and end point:DFS,pCR rate 2. Second objective and end point:OS 3. Exploratory objective and end point:cRR rate、relevant AE、Change of Scoring Scale、exploration for relevant biological indicators
Study Type
OBSERVATIONAL
Enrollment
200
immunotherapy anti-PD-1 or anti-PD-L1
targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor
chemotherapy
Oncology Department, Shanghai Chest Hospital
Shanghai, China
RECRUITINGDFS: disease free survival
The time length from randomization(mainly from the receipt of pathology and genetic diagnosis reports)to any of the following events: disease progression, disease recurrence or death from any cause. Disease progression or relapse will be assessed according to RECIST 1.1
Time frame: 36 months
pCR: pathologic complete response
the proportion of patients achieved pathologic complete response(lung and lymph node without tumor residual assessed by pathology review)
Time frame: 36 months
OS: Overall survival
The time length from the date of randomization (according to the received pathology and genetic diagnosis report) to the date of death.
Time frame: 36 months
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