A Single-arm Exploratory Study of Neoadjuvant Therapy

NCT05527808 | Unknown

• 1 other identifier: Tislelizumab-Neoadjuvant
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Adenocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes

  15-18 weeks after enrollment

• Descending rate of lymph nodes

  15-18 weeks after enrollment

• Number of Participants with Adverse Events

  through study completion, an average of 35weeks

• The time of surgery delay

  4-6weeks after completation of the last neoadjuvant therapy

Study Arms (1)

Neoadjuvant ICI combined with chemotherory

EXPERIMENTAL

intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles

Drug: Tislelizumab; Drug: pemetrexed; Drug: cis-platemum; Drug: or carboplatin

Interventions

Tislelizumab DRUG

200 mg ,intravenous injection ,Q3W 2-4 cycles

Neoadjuvant ICI combined with chemotherory

pemetrexed DRUG

500 mg/m2,intravenous injection ,Q3W 2-4 cycles

Neoadjuvant ICI combined with chemotherory

cis-platemum DRUG

60-75mg/m2 ,intravenous injection ,Q3W 2-4 cycles

Neoadjuvant ICI combined with chemotherory

or carboplatin DRUG

AUC(4-5) ,intravenous injection ,Q3W 2-4 cycles

Neoadjuvant ICI combined with chemotherory

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age 18-75 (boundary value included), no gender limitation;
• Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
• EGFR gene mutation positive (can be tested by tissue or blood samples);
• PD-L1 ≥ 1%
• ECOG PS score 0-1 (including boundary value);
• Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
• Meet the conditions for receiving platinum containing two-drug chemotherapy;
• The expected survival time is ≥3 months, and feasible surgery is planned;

You may not qualify if:

• Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
• there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
• 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

Sponsors & Collaborators

• Jun Liu: lead

Study Sites (1)

First Affiliated Hospital, Guangzhou Medical University

Guangzhou, Please Select, 510000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 28461257 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.

  PMID: 21789116 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.

  PMID: 9161793 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.

  PMID: 31194613 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.

  PMID: 24576776 BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

tislelizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Jun liu, Professor

  1First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry liang, Dr

CONTACT

15625064712; hengrui_liang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: September 6, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)