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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
| Wuhan TongJi Hospital | OTHER |
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The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance.
In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| third-generation EGFR-TKI monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) | Drug | Patients with advanced EGFR-mutated NSCLC who met the inclusion criteria and received third-generation EGFR-TKI (monotherapy or combined with brain radiotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Best Response | The time from the first day of third-generation EGFR-TKI treatment to the point at which the smallest tumor burden is observed on imaging studies. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Tumor Lesions at Best Response | the distribution of tumor lesions at the time when the smallest tumor burden is observed on imaging. Focus on whether the remaining lesions are suitable for consolidative stereotactic radiotherapy, per the relevant criteria endorsed by the NRG-BR001 study. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria
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Advanced EGFR-mutant NSCLC patients receiving third-generation EGFR-TKIs are enrolled
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Tongji Hospital | Wuhan | Hubei | 430030 | China | ||
| Shanghai Cancer Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
| C000718108 | aumolertinib |
| C000705711 | aflutinib |
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| Phenotypes of Disease Progression After Third-Generation EGFR-TKI Resistance |
Tumor distribution when disease progression occurs during third-generation EGFR-TKI treatment (disease progression is defined by RECIST 1.1 criteria). The pattern of progressive disease will be classified into the following three types based on imaging assessment:
|
| 5 years |
| Shanghai |
| Shanghai Municipality |
| 200050 |
| China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |