To hear about similar clinical trials, please enter your email below
Trial Title:
A Single-arm Exploratory Study of Neoadjuvant Therapy
NCT ID:
NCT05527808
Condition:
Lung Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Carboplatin
Pemetrexed
Tislelizumab
Conditions: Keywords:
Resectable II-IIIB
EGFR mutation and PD-L1≥1%
NSCLC
Neoadjuvant immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg ,intravenous injection ,Q3W 2-4 cycles
Arm group label:
Neoadjuvant ICI combined with chemotherory
Intervention type:
Drug
Intervention name:
pemetrexed
Description:
500 mg/m2,intravenous injection ,Q3W 2-4 cycles
Arm group label:
Neoadjuvant ICI combined with chemotherory
Intervention type:
Drug
Intervention name:
cis-platemum
Description:
60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles
Arm group label:
Neoadjuvant ICI combined with chemotherory
Intervention type:
Drug
Intervention name:
or carboplatin
Description:
AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles
Arm group label:
Neoadjuvant ICI combined with chemotherory
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate in clinical research;Fully understand and be Informed of
the study and sign the Informed Consent Form (ICF);Willing to follow and able to
complete all test procedures;
2. Age 18-75 (boundary value included), no gender limitation;
3. Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American
Joint Commission on Cancer, 8th Edition);
4. EGFR gene mutation positive (can be tested by tissue or blood samples);
5. PD-L1 ≥ 1%
6. ECOG PS score 0-1 (including boundary value);
7. Cardiopulmonary function is good, and the requirements for surgical resection for
radical treatment are confirmed;
8. Meet the conditions for receiving platinum containing two-drug chemotherapy;
9. The expected survival time is ≥3 months, and feasible surgery is planned;
Exclusion Criteria:
1. Any previous treatment for current lung cancer, including systemic therapy or
radiotherapy;
2. there are locally advanced unresectable diseases (regardless of disease stage) and
metastatic diseases (stage IV).
3. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled
systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung
disease, etc.Patients with any severe and/or uncontrolled disease or symptom
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital, Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
hengrui liang
Phone:
15625064712
Email:
hengrui_liang@163.com
Investigator:
Last name:
jun liu
Email:
Principal Investigator
Start date:
August 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Jun Liu
Agency class:
Other
Source:
Guangzhou Institute of Respiratory Disease
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527808
