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A Single-arm Exploratory Study of Neoadjuvant Therapy

NCT05527808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-06-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Jun Liu

    lead OTHER

Principal Investigators

  • Jun liu, Professor · 1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527808 on ClinicalTrials.gov