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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant ICI combined with chemotherory | Experimental | intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200 mg ,intravenous injection ,Q3W 2-4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated | 15-18 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To evaluate objective response rate (ORR) in neoadjuvant treatment | 6-12weeks after enrollment |
| pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henry liang, Dr | Contact | 15625064712 | hengrui_liang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun liu, Professor | 1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Guangzhou Medical University | Recruiting | Guangzhou | Please Select | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28461257 | Background | Chansky K, Detterbeck FC, Nicholson AG, Rusch VW, Vallieres E, Groome P, Kennedy C, Krasnik M, Peake M, Shemanski L, Bolejack V, Crowley JJ, Asamura H, Rami-Porta R; IASLC Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions. The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1109-1121. doi: 10.1016/j.jtho.2017.04.011. Epub 2017 Apr 28. | |
| 21789116 |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| pemetrexed | Drug | 500 mg/m2,intravenous injection ,Q3W 2-4 cycles |
|
| cis-platemum | Drug | 60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles |
|
| or carboplatin | Drug | AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles |
|
pCR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated |
| 15-18 weeks after enrollment |
| Descending rate of lymph nodes | Proportion of patients whose pathologic lymph node stage was reduced to N1/N0 by baseline radiographic assessment of N2 or N1 | 15-18 weeks after enrollment |
| Number of Participants with Adverse Events | To evaluate the safety profile(Number of Participants with Adverse Events) | through study completion, an average of 35weeks |
| The time of surgery delay | evaluate the interval time from the completation of last neoadjuvant therapy to surgery | 4-6weeks after completation of the last neoadjuvant therapy |
| minimally invasive surgery rate | explore different surgery manner rate after neoadjuvant | 4-6weeks after completation of the last neoadjuvant therapy |
| Background |
| Wozniak AJ, Gadgeel SM. Adjuvant therapy for resected non-small cell lung cancer. Ther Adv Med Oncol. 2009 Sep;1(2):109-18. doi: 10.1177/1758834009338634. |
| 9161793 | Background | Rosell R, Lopez-Cabrerizo MP, Astudillo J. Preoperative chemotherapy for stage IIIA non-small cell lung cancer. Curr Opin Oncol. 1997 Mar;9(2):149-55. doi: 10.1097/00001622-199703000-00008. |
| 31194613 | Background | Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13. |
| 24576776 | Background | NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25. |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |