A Single-arm Exploratory Study of Neoadjuvant Therapy

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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 greater than or equal to 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jun Liu
• Treatments: Carboplatin; Pemetrexed

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-IIIA non-squamous non-small cell lung cancer (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 expression is greater than or equal to 50% (Detect PD-L1 expression antibody clone no: Ventana SP263)

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).In patients with mediastinal lymph node involvement assessed by PET/CT, mediastinal lymph node samples from zones 4 (bilateral) and 7 should be collected to determine clinical staging to rule out stage IIIB disease.

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