Lung Adenocarcinoma
Conditions
Keywords
Resectable II-IIIB, EGFR mutation and PD-L1≥1%, NSCLC, Neoadjuvant immunotherapy
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.
Interventions
DRUGTislelizumab
200 mg ,intravenous injection ,Q3W 2-4 cycles
DRUGpemetrexed
500 mg/m2,intravenous injection ,Q3W 2-4 cycles
DRUGcis-platemum
60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles
DRUGor carboplatin
AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles
Sponsors
Jun Liu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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） | 15-18 weeks after enrollment | MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes | 15-18 weeks after enrollment | pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated |
| Descending rate of lymph nodes | 15-18 weeks after enrollment | Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1 |
| 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 | 6-12weeks after enrollment | To evaluate objective response rate (ORR) in neoadjuvant treatment |
| The time of surgery delay | 4-6weeks after completation of the last neoadjuvant therapy | evaluate the interval time from the completation of last neoadjuvant therapy to surgery |
| minimally invasive surgery rate | 4-6weeks after completation of the last neoadjuvant therapy | explore different surgery manner rate after neoadjuvant |
| Number of Participants with Adverse Events | through study completion, an average of 35weeks | To evaluate the safety profile(Number of Participants with Adverse Events) |
Countries
China
Contacts
Primary ContactHenry liang, Dr
Outcome results
None listed