A Single-arm Exploratory Study of Neoadjuvant Therapy (NCT05527808) | Clinical Trial Compass
UnknownNot Applicable
A Single-arm Exploratory Study of Neoadjuvant Therapy
China28 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Age 18-75 (boundary value included), no gender limitation;
. Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
. EGFR gene mutation positive (can be tested by tissue or blood samples);
. PD-L1 ≥ 1%
. ECOG PS score 0-1 (including boundary value);
. Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）
. Meet the conditions for receiving platinum containing two-drug chemotherapy;
Exclusion criteria
. Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
. there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
. 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