A Single-arm Exploratory Study of Neoadjuvant Therapy

Jun Liu

Status: Enrolling

Conditions: Lung Adenocarcinoma

Treatments: Drug: cis-platemum; Drug: pemetrexed; Drug: Tislelizumab; Drug: or carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05527808

Tislelizumab-Neoadjuvant

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Neoadjuvant ICI combined with chemotherory

Experimental group

Description:

intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles

Treatment:

Drug: pemetrexed

Drug: Tislelizumab

Drug: or carboplatin

Drug: cis-platemum