Neoadjuvant therapy for lung adenocarcinoma

Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"

This study is testing if a new combination of Tisleizumab and chemotherapy can help people with stage II-IIIA lung adenocarcinoma who have specific genetic markers, aiming to improve their chances of successful surgery and reduce complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Institute of Respiratory Disease (Academic / other)
• Drugs / interventions: chemotherapy, Tisleizumab, immunotherapy
• Locations: 1 site (Guangzhou, Please Select)
• Trial ID: NCT05527808 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Tisleizumab combined with chemotherapy as a neoadjuvant treatment for patients with stage II-IIIA lung adenocarcinoma that has EGFR mutations and PD-L1 expression of 1% or greater. The goal is to improve the pathological response rate, enhance the rate of complete surgical resection, and reduce perioperative complications. The study will also conduct biomarker analysis to identify potential candidates for neoadjuvant therapy and assess the efficacy and safety of this combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed stage II-IIIA lung adenocarcinoma, EGFR mutations, and PD-L1 expression of 1% or higher.

Not a fit: Patients with previously treated lung cancer or those with locally advanced unresectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better surgical outcomes and reduced complications for patients with specific types of lung cancer.

How similar studies have performed: Other studies have shown promising results with neoadjuvant immunotherapy approaches in similar patient populations, suggesting potential for success.

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

Where this trial is running

Guangzhou, Please Select

• First Affiliated Hospital, Guangzhou Medical University — Guangzhou, Please Select, China (Recruiting)

Study contacts

• Principal investigator: Jun liu, Professor — 1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China
• Study coordinator: Henry liang, Dr

Conditions Lung Adenocarcinoma; Resectable II-IIIB; EGFR mutation and PD-L1≥1%; NSCLC; Neoadjuvant immunotherapy