Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xiangya Hospital of Central South University | OTHER |
| Shanghai Chest Hospital | OTHER |
| West China Hospital | OTHER |
| Hunan Cancer Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genomic profiles detection | Other | The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 2 years |
| Progression-free survival (PFS) | Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC | 3 years |
| Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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 | 5 years |
| Disease Control Rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between tumor microenvironment signature and efficacy of 3rd EGFR-TKIs | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Stage IIIB-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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, The Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
Not provided
| OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Fudan University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Loudi Central Hospital | OTHER |
| ZhuZhou Central Hospital | OTHER |
| Xiangtan Central Hospital | OTHER |
| First People's Hospital of Chenzhou | OTHER |
| Yueyang Central Hospital | OTHER |
| Yongzhou Central Hospital | UNKNOWN |
| The First Affiliated Hospital of University of South China | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Shaoyang Central Hospital | UNKNOWN |
| Yiyang Central Hospital | UNKNOWN |
| Changsha Central Hospital | OTHER |
| The First People's Hospital of Guiyang | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| The First People's Hospital of Changde City | OTHER |
| Zhuzhou Second Hospital | UNKNOWN |
| First Hospital of Changsha | UNKNOWN |
| Hengyang Central Hospital | OTHER_GOV |
| Huaihua first people's Hospital | UNKNOWN |
| The First People's Hospital of Xiangtan | UNKNOWN |
| University of South China Affiliated Nanhua Hospital | UNKNOWN |
| Xiangxi Autonomous Prefecture People's Hospital | UNKNOWN |
| People's Hospital of Zhangjiajie | UNKNOWN |
| Second People's Hospital Of Huaihua | UNKNOWN |
| Hunan Academy of Traditional Chinese Medicine Affiliated Hospital | UNKNOWN |
| The Third Hospital of Changsha | UNKNOWN |
| Xiangya Changde Hospital | UNKNOWN |
| Changsha County first People's Hospital | UNKNOWN |
| Hunan Provincial Straight Hospital of Traditional Chinese Medicine | UNKNOWN |
| Liuyang Hospital of traditional Chinese Medicine | UNKNOWN |
| Second People's Hospital of Hunan | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Guiyang Public Health Treatment Center | UNKNOWN |
| The Affiliated Bethune Hospital of Shanxi Medical University | UNKNOWN |
| The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine | OTHER |
| Tongji Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
Not provided
Not provided
Not provided
| circulating tumor DNA detection | Other | The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing |
|
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) |
| 3 years |
| 3 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided