Clinical trial NCT05527808: A Single-arm Exploratory Study of Neoadjuvant Therapy
Official title: 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)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Adenocarcinoma
Keywords: Resectable II-IIIB
EGFR mutation and PD-L1≥1%
NSCLC
Neoadjuvant immunotherapy
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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）
timeFrame: 15-18 weeks after enrollment
Secondary outcomes:
measure: ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1
timeFrame: 6-12weeks after enrollment
measure: pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes
timeFrame: 15-18 weeks after enrollment
measure: Descending rate of lymph nodes
timeFrame: 15-18 weeks after enrollment
measure: Number of Participants with Adverse Events
timeFrame: through study completion, an average of 35weeks
measure: The time of surgery delay
timeFrame: 4-6weeks after completation of the last neoadjuvant therapy
measure: minimally invasive surgery rate
timeFrame: 4-6weeks after completation of the last neoadjuvant therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Guangzhou Medical University
state: Please Select
Study officials:
affiliation: 1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China
name: Jun liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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