NCT04197076

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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）

Detailed 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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	anti-PD-1 or anti-PD-L1	immunotherapy anti-PD-1 or anti-PD-L1
DRUG	EGFR-TKI, ALK inhibitor, ROS1 inhibitor	targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor
DRUG	investigator decided	chemotherapy

Timeline

• Start date: 2019-02-25
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2019-12-12
• Last updated: 2022-07-29

Locations

1 site across 1 country: China