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Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer Stages IIB-IIIB

Non Small Cell Lung Cancer Clinical Trial

Official title:
An Open, Observational Clinical Study, 2-3 Cycles Treatment as Neoadjuvant Therapy for NSCLC With Stage IIB-IIIB

Clinical Trial Summary

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）

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04197076
Study type Observational
Source Shanghai Chest Hospital
Contact Shun D Lu
Phone 86-21-62821990
Email shunlu@sjtu.edu.cn
Status Recruiting
Phase
Start date February 25, 2019
Completion date December 31, 2024
View Details
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