Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Osimertinib

Stage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.

The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing

Genomic profiles detection

The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing

circulating tumor DNA detection

Fang Wu, MD, PhD

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.

However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.

This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

1. The paraffin embeds tumor tissue at diognosis
2. Peripheral venous blood

Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and primary resistance and the efficacy of 3rd EGFR-TKIs during the enrolled observation process.

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC

The patients who don't achieve partial response or progress within 6 months are defined as the primary resistant group. The genomic profiles and ctDNA clearance detected by Next-generation gene sequencing will be compared between the primary drug-resistant group and sensitive-drug group.

Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status

The proportion of patients with a complete response or partial response or stable desease to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Xiangya Hospital of Central South University

Shanghai Chest Hospital

West China Hospital

Hunan Cancer Hospital

The Third Xiangya Hospital of Central South University

The First Affiliated Hospital of Xiamen University

Second Affiliated Hospital, School of Medicine, Zhejiang University

China-Japan Friendship Hospital

Fudan University

First Affiliated Hospital of Kunming Medical University

Loudi Central Hospital

ZhuZhou Central Hospital

Xiangtan Central Hospital

First People's Hospital of Chenzhou

Yueyang Central Hospital

Yongzhou Central Hospital

The First Affiliated Hospital of University of South China

Hunan Provincial People's Hospital

Shaoyang Central Hospital

Yiyang Central Hospital

Changsha Central Hospital

The first people's hospital of Guiyang

Wuhan Union Hospital, China

Renmin Hospital of Wuhan University

The First People's Hospital of Changde

Zhuzhou Second Hospital

First Hospital of Changsha

Hengyang Central Hospital

Huaihua first people's Hospital

The First People's Hospital of Xiangtan

University of South China Affiliated Nanhua Hospital

Xiangxi Autonomous Prefecture People's Hospital

People's Hospital of Zhangjiajie

Second People's Hospital Of Huaihua

Hunan Academy of Traditional Chinese Medicine Affiliated Hospital

The Third Hospital of Changsha

Xiangya Changde Hospital

Changsha County first People's Hospital

Hunan Provincial Straight Hospital of Traditional Chinese Medicine

Liuyang Hospital of traditional Chinese Medicine

Second People's Hospital of Hunan

First Affiliated Hospital of Guangxi Medical University

Guiyang Public Health Treatment Center

The Affiliated Bethune Hospital of Shanxi Medical University

The First Affiliated Hospital of Hunan University of Chinese Medicine

Tongji Hospital

The First Affiliated Hospital of Nanchang University

Second Xiangya Hospital of Central South University

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)	NCT05598528	Lung Cancer, No... EGFR Gene Mutat... EGFR-TKI Resist... Primary Resista... Circulating Tum...	Genomic profile... circulating tum...	18 Years -	Second Xiangya Hospital of Central South University
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)	NCT05598528	Lung Cancer, No... EGFR Gene Mutat... EGFR-TKI Resist... Primary Resista... Circulating Tum...	Genomic profile... circulating tum...	18 Years -	Second Xiangya Hospital of Central South University

Spots Global Cancer Trial Database for genomic profiles detection