NCT05527808

A Single-arm Exploratory Study of Neoadjuvant Therapy

Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Jun Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg ,intravenous injection ,Q3W 2-4 cycles
DRUG	pemetrexed	500 mg/m2,intravenous injection ,Q3W 2-4 cycles
DRUG	cis-platemum	60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles
DRUG	or carboplatin	AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2022-09-06
• Last updated: 2023-06-08

Locations

1 site across 1 country: China